US10792152B2

Movatterモバイル変換

Info

Publication number: US10792152B2
Application number: US15/919,452
Authority: US
Inventors: Tal Reich; Amir Gross; Tal Sheps
Original assignee: Valtech Cardio Ltd
Current assignee: Valtech Cardio Ltd
Priority date: 2011-06-23
Filing date: 2018-03-13
Publication date: 2020-10-06
Also published as: US12409032B2; US20190167425A1; US20210015617A1

Abstract

A method is provided, including, during a percutaneous transcatheter procedure, placing an annuloplasty device entirely around an annulus of a mitral valve of a subject in a closed loop. The annuloplasty device includes a flexible sleeve, which is fastened to the annulus by coupling a plurality of tissue anchors to a posterior portion of the annulus, without coupling any tissue anchors to any anterior portion of the annulus between left and right fibrous trigones of the annulus. After (a) placing the annuloplasty device entirely around the annulus in the closed loop and (b) fastening the flexible sleeve to the annulus, a longitudinal portion of the flexible sleeve is longitudinally contracted. Other embodiments are also described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. application Ser. No. 14/589,100, filed Jan. 5, 2015. The present application is also a continuation-in-part of U.S. application Ser. No. 15/474,543, filed Mar. 30, 2017, which is a continuation of U.S. application Ser. No. 14/128,756, filed Feb. 6, 2014, now U.S. Pat. No. 9,662,209, which is the U.S. national stage of International Application PCT/IL2012/000250, filed Jun. 21, 2012, which (a) is a continuation-in-part of U.S. application Ser. No. 13/167,444, filed Jun. 23, 2011, now U.S. Pat. No. 9,011,530, (b) is a continuation-in-part of U.S. application Ser. No. 13/167,476, filed Jun. 23, 2011, now U.S. Pat. No. 8,940,044, and (c) is a continuation-in-part of U.S. application Ser. No. 13/167,492, filed Jun. 23, 2011, now U.S. Pat. No. 8,926,697, which is assigned to the assignee of the present application and each of the foregoing applications is incorporated herein by reference.

FIELD OF THE APPLICATION

Some applications of the present invention relate in general to valve repair, and more specifically to repair of an atrioventricular valve of a patient.

BACKGROUND OF THE APPLICATION

Dilation of the annulus of the mitral valve prevents the valve leaflets from fully coapting when the valve is closed. Mitral regurgitation of blood from the left ventricle into the left atrium results in increased total stroke volume and decreased cardiac output, and ultimate weakening of the left ventricle secondary to a volume overload and a pressure overload of the left atrium. Dilation of the annulus is sometimes treated by annuloplasty, in which a partial or full ring is implanted around the annulus to cause the leaflets to coapt when the valve is closed.

SUMMARY

In some applications of the present invention, an implantable structure is provided that comprises a flexible sleeve having first and second sleeve ends, a contracting assembly, and a plurality of tissue anchors. The contracting assembly is configured to longitudinally contract the sleeve, and comprises a contracting mechanism and a longitudinal contracting member having first and second member ends. The contracting mechanism is disposed longitudinally at a first site of the sleeve, and the second member end is coupled to the sleeve longitudinally at a second site longitudinally between the first site and the second sleeve end, exclusive. The contracting member also has a first member end portion, which extends from the first member end toward the second member end along only a longitudinal portion of the contracting member, and is coupled to the contracting mechanism. A first portion of the sleeve longitudinally extends from the first sleeve end toward the first site, and a second portion of the sleeve longitudinally extends from the second sleeve end toward the second site. The sleeve is arranged in a closed loop, such that the first and second portions of the sleeve together define a longitudinally overlapping portion of the sleeve. The implantable structure is configured such that the contracting assembly applies a longitudinal contracting force only between the first and the second sites, and not along the overlapping portion. The longitudinal contracting force longitudinally contracts at least a portion of the sleeve only between the first and the second sites, and not along the overlapping portion. Typically, the contracting member extends along neither the first nor the second portion of the sleeve.

In some applications of the present invention, the contracting assembly includes one or more longitudinal contracting members coupled to the contracting mechanism. The implantable structure is placed completely around an annulus of an atrioventricular valve of a subject, such that none of the one or more longitudinal contracting members is positioned along an anterior portion of the annulus between fibrous trigones of the valve. The implantable structure is fastened to the annulus. The contracting assembly is then actuated to contract a longitudinal portion of the sleeve not positioned along the anterior portion of the annulus. Tightening of the implantable structure therefore tightens at least a portion of the posterior portion of the annulus, while preserving the length of the anterior portion of the annulus. (The anterior portion of the annulus should generally not be contracted because its tissue is part of the skeleton of the heart.) However, the portion of the sleeve deployed along the anterior portion of the annulus prevents dilation of the anterior annulus, because the sleeve is anchored at both ends of the anterior annulus, and the sleeve typically comprises a longitudinally non-extensible material. This deployment configuration may help prevent long-term resizing of annulus, especially the anterior annulus, which sometimes occurs after implantation of partial annuloplasty rings, such as C-bands.

In some applications of the present invention, one or more of the tissue anchors are coupled to the sleeve at respective third sites longitudinally between the second site and the second sleeve end, exclusive. Typically, the implantable structure is configured such that the contracting assembly applies a longitudinal contracting force only between the first and the second sites. The longitudinal contracting force contracts at least a portion of the sleeve only between the first and the second sites. Providing the one or more anchors beyond the ends of the contracting member generally distributes force applied by contraction of the contracting assembly over the tissue interfaces of these anchors. In contrast, in some configurations of the implantable structure in which anchors are not provided beyond the ends of the contracting member, the force applied by the contracting assembly is applied predominantly to the single anchor nearest the first end of the contracting member, and the single anchor nearest the second end of the contracting member.

For some applications, at least two of the tissue anchors are coupled to the sleeve at respective third sites longitudinally between the second member end and the second sleeve end, exclusive. For some applications, the second site is at least 5 mm from the second sleeve end, measured when the sleeve is in a straight, relaxed, non-contracted state, such as at least 9 mm, e.g., at least 18 mm. For some applications, the second site is at a longitudinal distance from the second sleeve end, which distance is no greater than 30% of a total length of the sleeve, the distance and length measured when the sleeve is in the straight, relaxed, non-contracted state. For some applications, at least three of the tissue anchors are coupled to the sleeve alongside the contracting member, longitudinally between the first and second sites, exclusive. Typically, the sleeve is substantially longitudinally non-extensible.

For some applications, the sleeve has first and second sleeve ends, and first and second portions that longitudinally extend from the first and the second sleeve ends, respectively. The sleeve is arranged in a closed loop, such that the first and second portions of the sleeve together define a longitudinally overlapping portion of the sleeve positioned at least partially along the anterior portion of the annulus, and none of the one or more longitudinal contracting members is positioned along the overlapping portion of the sleeve. For some applications, at least one of the tissue anchors penetrates both the first and second portions of the sleeve at the overlapping portion. Such a mutual anchor helps ensure that the first and second portions remain tightly coupled together and to the tissue, so that the sleeve retains its closed loop shape. Alternatively, for some applications, the sleeve is shaped so as to define an integrally closed loop having no sleeve ends.

The implantable structure, when in this closed-loop configuration, is deployed around the entire annulus of the native valve, including an anterior portion of the annulus (on the aortic side of the valve) between the fibrous trigones. Typically, the contracting member does not extend along the portion of the sleeve deployed along the anterior portion of the annulus, and thus does not extend along the first portion, the second portion, or the overlapping portion of the sleeve. The portion of the sleeve deployed along the anterior portion of the annulus (between the trigones) is thus non-contractible. As mentioned above, tightening of the implantable structure therefore tightens the posterior portion of the annulus, while preserving the length of the anterior portion of the annulus. For some applications, this deployment configuration may also help achieve a closed loop that serves as a base ring to which a prosthetic valve is coupled.

In some applications of the present invention, the implantable structure further comprises an elongated linking member, which is positioned along an anterior portion of the annulus, so as to join the ends of the implantable structure in a complete loop. Over time after implantation, the linking member becomes fixed to the anterior portion of the annulus, thereby helping prevent long-term dilation of the anterior annulus. Typically, at least a portion of the linking member is disposed within and covered by the sleeve, into and/or over which fibrous tissue grows over time, helping anchor the linking member to tissue of the anterior annulus. Typically, in this configuration of the implantable structure, none of the anchors is coupled to the anterior portion of the annulus.

A first end of the linking member is typically fixed between 2 and 6 cm from a first end of the sleeve. A second end of the linking member is positioned within 1.5 cm of the same end of the sleeve, either protruding from the end of the sleeve, or recessed within the sleeve. The second end of the linking member comprises (e.g., is shaped so as to define) a first coupling element. The implantable structure further comprises a second coupling element, which is configured to be coupleable to the first coupling element. The second coupling element is coupled to the implantable structure within 1.5 cm of the second end of the sleeve. The second coupling element may be coupled to the housing, directly to the sleeve, or otherwise coupled to the implantable structure. Typically, the linking member is substantially longitudinally non-extensible, i.e., its length is fixed.

For some applications, the linking member is configured as a spring, which is typically curved, so as to be elastic in a radial direction, i.e., to be compressible like a bow or deflected beam. In these applications, the linking member is oriented such that it is pressed by elasticity against the anterior portion of the mitral annulus, i.e., the outer wall of the aorta, thereby holding the sleeve covering the linking member against the aortic wall. For some applications, at least two of the tissue anchors are coupled to the sleeve at respective, different longitudinal sites alongside the linking member, within 6 cm of the first end of the linking member. These tissue anchors may help set the proper direction of curvature of the linking member, for applications in which the linking member is curved.

For some applications, the implantable structure further comprises an elongated radial-force application element, which is disposed entirely within a first longitudinal portion of the sleeve. The elongated radial-force application element is configured to apply a force against a wall of the first longitudinal portion of the sleeve in at least one radially-outward direction. The applied force pushes the first longitudinal portion of the sleeve against tissue of the left atrium, such as against tissue of the annulus and/or the atrial wall, so as to inhibit blood flow between the sleeve and the tissue. It is generally desirable to inhibit blood flow between the sleeve and the annulus on anterior side, to avoid creating turbulence. When implanting the implantable structure, the elongated radial-force application element is placed along the anterior portion of the annulus, between the fibrous trigones.

For some applications, the elongated radial-force application element comprises a springy element. For some applications, at least a portion of the springy element is curved at least partially about an inner surface of the wall of the sleeve.

For some applications, the elongated radial-force application element is rotationally asymmetric and not helically symmetric. For other applications, the elongated radial-force application element is helically symmetric; for these applications, the springy element typically comprises a coiled spring.

For some applications, the sleeve has first and second sleeve ends. For some applications, the elongated radial-force application element has (a) a first radial-force-application-element longitudinal end that is between 2 and 6 cm from the first sleeve end, measured when the sleeve is fully longitudinally extended, and (b) a second radial-force-application-element longitudinal end that is within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended.

For some applications, the annuloplasty ring further comprises (a) a first coupling element, which is coupled to the annuloplasty ring within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended, and (b) a second coupling element. The second coupling element is configured to be coupleable to the first coupling element, and is fixed to the implantable structure (e.g., the annuloplasty ring) within 1.5 cm of the second sleeve end, measured when the sleeve is fully longitudinally extended. For some applications, at least one of the first and second coupling elements comprises a hook.

For some applications, the contracting mechanism (e.g., the housing thereof) is fixed along the sleeve within 30 mm, such as within 15 mm, of the second sleeve end (i.e., the same end of the sleeve near which the second coupling element is coupled), measured when the sleeve is fully longitudinally extended. For example, the contracting mechanism (e.g., the housing thereof) may be fixed at the second sleeve end. Alternatively, for some applications, the contracting mechanism (e.g., the housing thereof) is fixed at least 5 mm from the second sleeve end, e.g., between 5 and 30 mm, such as between 5 and 15 mm, from the second sleeve end. The second coupling element may be coupled to the contracting mechanism (e.g., to the housing).

For some applications, the annuloplasty ring further comprises a substantially longitudinally non-extensible linking member, i.e., a length thereof is substantially constant, i.e., cannot be longitudinally stretched, under normal usage conditions. The linking member typically helps prevent long-term dilation of the anterior annulus. The linking member is typically configured not to apply any force to the wall of the first longitudinal portion of the sleeve. Typically, the linking member is not configured as a spring.

For some applications, at least the first longitudinal portion of the sleeve is substantially longitudinally non-extensible, i.e., a length thereof is substantially constant, i.e., cannot be longitudinally stretched, under normal usage conditions. In these applications, the first longitudinal portion typically helps prevent long-term dilation of the anterior annulus. For some applications, the first coupling element is fixed to the wall of the sleeve within 1.5 cm offirst sleeve end51, measured when the sleeve is fully longitudinally extended. The implantable structure typically does not comprise the linking member in these applications. In these applications, at least the first longitudinal portion of the sleeve is substantially longitudinally non-extensible, and the first longitudinal portion typically helps prevent long-term dilation of the anterior annulus.

For some applications, during placement, after fastening the sleeve to the portion of the annulus, the healthcare professional twists the first longitudinal portion of the sleeve. Optionally, such twisting may serve one or both of the following purposes: (1) the twisting may store energy in the springy element for exertion of torque against the wall of the sleeve, and (2) the twisting may rotationally align the springy element in the desired radial direction. Alternatively or additionally to twisting for the first of these purposes, the springy element may be pre-loaded (twisted) to store energy before implantation in the subject, such as immediately before implantation or during manufacture.

For some applications, the sleeve is fastened to the annulus by coupling a plurality of tissue anchors to the annulus. The tissue anchors are coupled with:

- a first non-zero longitudinal density along a posterior portion of the annulus between the left and right fibrous trigones of the annulus, including the trigones, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the posterior portion of the annulus divided by (b) a length of the posterior portion of the annulus (measured along the annulus),
- and a second non-zero longitudinal density along the anterior portion of the annulus between the left and right fibrous trigones of the annulus, not including the trigones, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the anterior portion of the annulus divided by (b) a length of the anterior portion of the annulus (measured along the annulus).

The first longitudinal density is greater than the second longitudinal density. For some applications, the first longitudinal density is at least twice the second longitudinal density, such as at least 2.5 the second longitudinal density, e.g., at least 3 times the second longitudinal density. After the tissue anchors are fastened to the annulus, a longitudinal portion of the sleeve is contracted, such as by causing the longitudinal contracting member to apply a force to the longitudinal portion of the sleeve, such as by actuating the contracting assembly.

For some applications, the sleeve is fastened to the annulus by coupling a plurality of tissue anchors to the annulus, including first, second, and third tissue anchors, as follows:

- one or more first tissue anchors are coupled to the annulus along a lateral scallop (P1) of the posterior leaflet, with a first longitudinal density, which density is equal to (a) a number of the first tissue anchors coupled to the annulus along the lateral scallop (P1) divided by (b) a length of the lateral scallop (P1) along the annulus,
- a plurality of second tissue anchors (e.g., at least 3 tissue anchors) are coupled to the annulus along a middle scallop (P2) of the posterior leaflet, with a second longitudinal density, which density is equal to (a) a number of the second tissue anchors coupled to the annulus along the middle scallop (P2) divided by (b) a length of the middle scallop (P2) along the annulus, and
- one or more third tissue anchors are coupled to the annulus along a medial scallop (P3) of the posterior leaflet, with a third longitudinal density, which density is equal to (a) a number of the third tissue anchors coupled to the annulus along the medial scallop (P3) divided by (b) a length of the medial scallop (P3) along the annulus.

The longitudinal densities are characterized by at least one of the following: (a) the second longitudinal density is at least twice the first longitudinal density, and (b) the second longitudinal density is at least twice the third longitudinal density. For some applications, both (a) the second longitudinal density is at least twice the first longitudinal density, and (b) the second longitudinal density is at least twice the third longitudinal density.

For some applications, the tissue anchors, including the second tissue anchors, comprise respective anchor heads and tissue coupling elements. Typically, the anchor heads are circular; alternatively, they have another shape, such as of an ellipse or a polygon (e.g., a hexagon or a square). The plurality of tissue anchors are coupled to the annulus such that, after the longitudinal portion of the sleeve has been contracted, each of the anchor heads of at least two of the second tissue anchors coupled along the middle scallop (P2) touches at least one longitudinally-adjacent anchor head; for example, each of the anchor heads of at least three of tissue anchors touches at least one longitudinally-adjacent anchor head320.

Typically, before the longitudinal portion of the sleeve has been contracted, the anchor heads of the at least two of the second tissue anchors do not touch any longitudinally-adjacent the anchor heads. Before the longitudinal portion of the sleeve has been contracted, the anchors are coupled to the sleeve and tissue at distances between the anchors that are less than the planned distances that the anchors move toward each other during contraction of the longitudinal portion of the sleeve. As a result, the anchor heads touch each other upon such contraction.

This touching of the longitudinally-adjacent anchors heads inhibits longitudinal contraction of the sleeve in the longitudinal area of these anchors, so as to facilitate reshaping of the annulus in a desired manner. These longitudinally-adjacent the anchor heads thus are dual-function, and serve to both anchor their respective anchors to the sleeve and to inhibit contraction of the sleeve.

For some applications, the plurality of tissue anchors is coupled to the annulus such that, after the longitudinal portion of the sleeve has been contracted:

- none of the anchor heads of the first tissue anchors coupled along the lateral scallop (P1) touches any of the other anchor heads of the tissue anchors; and/or
- none of the anchor heads of the third tissue anchors coupled along the medial scallop (P3) touches any of the other anchor heads of the tissue anchors.

For some applications, the plurality of tissue anchors are coupled to the annulus such that, after the longitudinal portion of the sleeve has been contracted:

- a first number of the anchor heads of the first tissue anchors coupled along the lateral scallop (P1) touch at least one longitudinally-adjacent anchor head, and (b) a second number of the anchors heads of the tissue anchors coupled along the middle scallop (P2) touch at least one longitudinally-adjacent anchor head, the second number greater than the first number; and/or
- a second number of the anchor heads of the second tissue anchors coupled along the middle scallop (P2) touch at least one longitudinally-adjacent anchor head, and (b) a third number of the anchors heads of the third tissue anchors coupled along the medial scallop (P3) touch at least one longitudinally-adjacent anchor head, the second number greater than the third number.

For some applications, the sleeve is fastened to the annulus by coupling a plurality of tissue anchors to the annulus, such that:

- a first set of exactly three of the tissue anchors is disposed in succession along a first portion of the longitudinal contracting member with a first distance between longitudinal-end tissue anchors of the first set, measured along the annulus, and
- a second set of exactly three of the tissue anchors is disposed in succession along a second portion of the longitudinal contracting member with a second distance between longitudinal-end tissue anchors of the second set, measured along the annulus,

The first distance equals at least twice the second distance, such as at least 2.5 times the second distance, e.g., at least 3 times the second distance. The first distance is measured between closest portions of the longitudinal-end tissue anchors of the first set, and the second distance is measured between closest portions of the longitudinal-end tissue anchors of the second set. The first and second sets do not share any common tissue anchors. After the tissue anchors are fastened to the annulus, a longitudinal portion of the sleeve is contracted. Providing the greater number of anchoring points with the second set better distributes forces among the anchors of this set.

For some applications, the contracting mechanism comprises a rotatable structure, and a housing in which the rotatable structure is positioned. The contracting mechanism and the longitudinal contracting member are arranged such that rotation of the rotatable structure contracts the implantable structure. Typically, an anchor deployment manipulator is advanced into a lumen of the sleeve, and, from within the lumen, deploys the anchors through a wall of the sleeve and into cardiac tissue, thereby anchoring the sleeve around a portion of a valve annulus.

For some applications, the implantable structure comprises an adjustable annuloplasty ring for repairing a dilated valve annulus of an atrioventricular valve, such as a mitral valve. The annuloplasty ring may be used for treating functional mitral regurgitation (FMR) or degenerative mitral valve disease. For other applications, a prosthetic heart valve is further provided, which is configured to be coupled to the sleeve.

For some applications in which the implantable structure is implanted around the annulus of a valve, the implantable structure may be advanced toward the annulus of a valve in any suitable procedure, e.g., a transcatheter procedure, a percutaneous procedure, a minimally invasive procedure, or an open heart procedure.

There is therefore provided, in accordance with an application of the present invention, a method including:

providing an annuloplasty ring, which includes (a) a flexible sleeve, and (b) a contracting assembly;

during a percutaneous transcatheter procedure, placing the flexible sleeve entirely around an annulus of a mitral valve of a subject in a closed loop;

fastening the sleeve to the annulus by coupling a plurality of tissue anchors to a posterior portion of the annulus, without coupling any tissue anchors to an anterior portion of the annulus between left and right fibrous trigones of the annulus; and

thereafter, contracting a longitudinal portion of the sleeve.

For some applications, the contracting assembly further includes a longitudinal contracting member and a locking mechanism, and the method further includes, after contracting the longitudinal portion of the sleeve, locking the longitudinal contracting member with respect to the contracting assembly using the locking mechanism.

For some applications, contracting the longitudinal portion of the sleeve includes actuating the contracting assembly to contract the longitudinal portion of the sleeve.

For some applications, providing the annuloplasty ring includes providing the annuloplasty ring in which the sleeve is shaped so as to define an integrally closed loop having no sleeve ends.

For some applications, the sleeve has first and second sleeve ends, and placing the sleeve includes introducing the flexible sleeve into a left atrium while the first and the second sleeve ends are not coupled to each other; and thereafter, in the left atrium, arranging the flexible sleeve entirely around the annulus to form the closed loop.

For some applications, the annuloplasty ring further includes an elongated linking member, which is coupled to and disposed within the sleeve, and placing the flexible sleeve entirely around the annulus includes placing the linking member along the anterior portion of the annulus.

For some applications, the linking member is configured as a spring. For some applications, the linking member is curved. For some applications, the linking member has a length of between 2 and 6 cm. For some applications, the linking member includes metal. For some applications, the linking member is substantially longitudinally non-extensible.

For some applications:

the linking member includes a first coupling element,

the annuloplasty ring includes a second coupling element, which is configured to be coupleable to the first coupling element, and which is coupled to the annuloplasty ring within 1.5 cm of one of the first and the second sleeve ends, measured when the sleeve is fully longitudinally extended,

the first and the second coupling elements are configured to provide an adjustable-length connection between the linking member and the one of the first and the second sleeve ends, and

placing the linking member along the anterior portion of the annulus includes setting an effective length of the linking member while coupling the first and the second coupling elements together.

For some applications:

the linking member is disposed within a longitudinal portion of the sleeve,

the annuloplasty ring further includes an elongated radial-force application element, which is disposed within the longitudinal portion of the sleeve, and

placing the linking member includes placing the elongated radial-force application element along the anterior portion of the annulus, such that the elongated radial-force application element applies a force against a wall of the longitudinal portion of the sleeve in at least one radially-outward direction.

For some applications, placing the elongated radial-force application element includes placing the elongated radial-force application element along the anterior portion of the annulus, such that the elongated radial-force application element pushes the longitudinal portion of the sleeve against atrial tissue.

For some applications, the elongated radial-force application element is springy.

For some applications, the elongated radial-force application element includes an inflatable element.

For some applications, the linking member is not configured as a spring.

For some applications, placing the linking member includes placing the linking member such that the linking member does not apply any force to the wall of the longitudinal portion of the sleeve.

For some applications, at least 90% of a length of the linking member is straight when in a resting state.

For some applications, the linking member is substantially longitudinally non-extensible.

For some applications, the elongated radial-force application element has a length of between 2 and 6 cm, measured when the sleeve is fully longitudinally extended.

For some applications:

the longitudinal portion of the sleeve is a first longitudinal portion of the sleeve,

the contracting assembly includes (a) a contracting mechanism, and (b) a longitudinal contracting member, which is arranged along a second longitudinal portion of the sleeve that is entirely longitudinally distinct from the first longitudinal portion of the sleeve, and

the elongated radial-force application element is disposed entirely within the first longitudinal portion of the sleeve.

There is further provided, in accordance with an application of the present invention, a method including:

fastening the sleeve to the annulus by coupling a plurality of tissue anchors to the annulus, with:

a first non-zero longitudinal density of the tissue anchors along a posterior portion of the annulus between left and right fibrous trigones of the annulus, including the trigones, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the posterior portion of the annulus divided by (b) a length of the posterior portion of the annulus, and

a second non-zero longitudinal density of the tissue anchors along an anterior portion of the annulus between left and right fibrous trigones of the annulus, not including the trigones, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the anterior portion of the annulus divided by (b) a length of the anterior portion of the annulus, wherein the first longitudinal density is greater than the second longitudinal density; and

thereafter, contracting a longitudinal portion of the sleeve.

For some applications, the first longitudinal density is at least twice the second longitudinal density.

For some applications, the sleeve has first and second sleeve ends, and placing the flexible sleeve includes introducing the flexible sleeve into a left atrium while the first and the second sleeve ends are not coupled to each other; and thereafter, in the left atrium, arranging the flexible sleeve entirely around the annulus to form the closed loop.

For some applications, the linking member has a length of between 2 and 6 cm.

For some applications, the linking member includes metal.

For some applications:

the linking member includes a first coupling element,

For some applications:

the linking member is disposed within a longitudinal portion of the sleeve,

For some applications, the linking member is not configured as a spring.

For some applications:

There is still further provided, in accordance with an application of the present invention, a method including:

during a percutaneous transcatheter procedure, placing the flexible sleeve at least partially around an annulus of a mitral valve of a subject;

a first longitudinal density of the tissue anchors along a lateral scallop (P1) of a posterior leaflet of the mitral valve, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the lateral scallop (P1) divided by (b) a length of the lateral scallop (P1) along the annulus,

a second longitudinal density of the tissue anchors along a middle scallop (P2) of the posterior leaflet, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the middle scallop (P2) divided by (b) a length of the middle scallop (P2) along the annulus, and

a third longitudinal density of the tissue anchors along a medial scallop (P3) of the posterior leaflet, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the medial scallop (P3) divided by (b) a length of the medial scallop (P3) along the annulus, wherein the longitudinal densities are characterized by at least one of the following: (a) the second longitudinal density is at least twice the first longitudinal density, and (b) the second longitudinal density is at least twice the third longitudinal density; and

thereafter, contracting a longitudinal portion of the sleeve.

For some applications, both (a) the second longitudinal density is at least twice the first longitudinal density, and (b) the second longitudinal density is at least twice the third longitudinal density.

For some applications, the second longitudinal density is at least twice the first longitudinal density.

For some applications, the second longitudinal density is at least twice the third longitudinal density.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling at least 3 tissue anchors to the annulus along the middle scallop (P2).

For some applications, the tissue anchors have respective anchor heads, and coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, after contracting the longitudinal portion of the sleeve, each of the anchor heads of at least two of the tissue anchors coupled along the middle scallop (P2) touches at least one longitudinally-adjacent anchor head.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, before contracting the longitudinal portion of the sleeve, the anchor heads of the at least two of the tissue anchors do not touch the at least one longitudinally-adjacent anchor head.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, after contracting the longitudinal portion of the sleeve, each of the anchor heads of at least three of the tissue anchors coupled along the middle scallop (P2) touches at least one longitudinally-adjacent anchor head.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, after contracting the longitudinal portion of the sleeve, none of the anchor heads of the tissue anchors coupled along the lateral scallop (P1) touches any of the other anchor heads of the tissue anchors.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, after contracting the longitudinal portion of the sleeve, none of the anchor heads of the tissue anchors coupled along the medial scallop (P3) touches any of the other anchor heads of the tissue anchors.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, after contracting the longitudinal portion of the sleeve, (a) none of the anchor heads of the tissue anchors coupled along the lateral scallop (P1) touches any of the other anchor heads of the tissue anchors, and (b) none of the anchor heads of the tissue anchors coupled along the medial scallop (P3) touches any of the other anchor heads of the tissue anchors.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, after contracting the longitudinal portion of the sleeve, (a) a first number of the anchor heads of the tissue anchors coupled along the lateral scallop (P1) touch at least one longitudinally-adjacent anchor head, and (b) a second number of the anchors heads of the tissue anchors coupled along the middle scallop (P2) touch at least one longitudinally-adjacent anchor head, the second number greater than the first number.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, after contracting the longitudinal portion of the sleeve, (a) a second number of the anchor heads of the tissue anchors coupled along the middle scallop (P2) touch at least one longitudinally-adjacent anchor head, and (b) a third number of the anchors heads of the tissue anchors coupled along the medial scallop (P3) touch at least one longitudinally-adjacent anchor head, the second number greater than the third number.

For some applications, coupling the plurality of tissue anchors to the annulus includes coupling the plurality of tissue anchors to the annulus such that, after contracting the longitudinal portion of the sleeve:

a first number of the anchor heads of the tissue anchors coupled along the lateral scallop (P1) touch at least one longitudinally-adjacent anchor head,

a second number of the anchors heads of the tissue anchors coupled along the middle scallop (P2) touch at least one longitudinally-adjacent anchor head, and

a third number of the anchors heads of the tissue anchors coupled along the medial scallop (P3) touch at least one longitudinally-adjacent anchor head, the second number greater than the first number, and the second number greater than the third number.

For some applications, the sleeve has first and second sleeve ends, and placing the sleeve includes introducing the flexible sleeve into a left atrium while the first and the second sleeve ends are not coupled to each other.

For some applications, placing the sleeve includes arranging the sleeve entirely around the annulus to form a closed loop, after introducing the flexible sleeve into the left atrium while the first and the second sleeve ends are not coupled to each other.

There is additionally provided, in accordance with an application of the present invention, a method including:

providing an annuloplasty ring, which includes (a) a flexible sleeve and (b) a contracting assembly, which includes a longitudinal contracting member;

fastening the sleeve to the annulus by coupling a plurality of tissue anchors to the annulus, such that:

a first set of exactly three of the tissue anchors is disposed in succession along the longitudinal contracting member with a first distance between longitudinal-end tissue anchors of the first set, measured along the annulus, and

a second set of exactly three of the tissue anchors is disposed in succession along the longitudinal contracting member with a second distance between longitudinal-end tissue anchors of the second set, measured along the annulus, wherein the first distance equals at least twice the second distance, and wherein the first and the second sets do not share any common tissue anchors; and

thereafter, contracting a longitudinal portion of the sleeve by causing the longitudinal contracting member to apply a contracting force to the longitudinal portion of the sleeve.

For some applications, the contracting assembly further includes a locking mechanism, and the method further includes, after contracting the longitudinal portion of the sleeve, locking the longitudinal contracting member with respect to the contracting assembly using the locking mechanism.

For some applications, contracting the longitudinal portion of the sleeve includes actuating the contracting assembly to contract the longitudinal portion of the sleeve by causing the longitudinal contracting member to apply the contracting force to the longitudinal portion of the sleeve.

There is yet additionally provided, in accordance with an application of the present invention, apparatus including an annuloplasty ring, which includes:

a flexible sleeve, having first and second sleeve ends;

a contracting assembly;

a first coupling element, which is coupled to the annuloplasty ring within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended;

a second coupling element, which is configured to be coupleable to the first coupling element, and which is coupled to the annuloplasty ring within 1.5 cm of the second sleeve end, measured when the sleeve is fully longitudinally extended; and

an elongated springy element, which is disposed entirely within a longitudinal portion of the sleeve, wherein the springy element has (a) a first springy-element longitudinal end that is between 2 and 6 cm from the first sleeve end, measured when the sleeve is fully longitudinally extended, and (b) a second springy-element longitudinal end that is within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended,

wherein the springy element is configured to press the longitudinal portion of the sleeve against tissue.

For some applications, the contracting assembly further includes a longitudinal contracting member and a locking mechanism, which is configured to lock the longitudinal contracting member with respect to the contracting assembly.

For some applications, the longitudinal portion of the sleeve is a first longitudinal portion of the sleeve, and the contracting assembly is configured to contract at least a portion of a second longitudinal portion of the sleeve, which second longitudinal portion is entirely longitudinally distinct from the first longitudinal portion.

For some applications, a first end of the elongated springy element includes the first coupling element.

There is also provided, in accordance with an application of the present invention, a method including:

providing an annuloplasty ring, which includes (a) a flexible sleeve, having first and second sleeve ends, (b) a contracting assembly, (c) a first coupling element, which is coupled to the annuloplasty ring within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended, (d) a second coupling element, which is configured to be coupleable to the first coupling element, and which is coupled to the annuloplasty ring within 1.5 cm of the second sleeve end, measured when the sleeve is fully longitudinally extended, and (e) an elongated springy element, which is disposed entirely within a first longitudinal portion of the sleeve, wherein the springy element has (a) a first springy-element longitudinal end that is between 2 and 6 cm from the first sleeve end, measured when the sleeve is fully longitudinally extended, and (b) a second springy-element longitudinal end that is within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended;

during a percutaneous transcatheter procedure, placing the flexible sleeve around a portion of an annulus of an atrioventricular valve of a subject, which portion includes a posterior portion of the annulus;

placing the first longitudinal portion of the sleeve along an anterior portion of the annulus between fibrous trigones of the valve;

fastening the flexible sleeve to the portion of the annulus, such that the springy element presses the first longitudinal portion of the sleeve against tissue;

coupling the first and the second coupling elements together; and

contracting at least a portion of a second longitudinal portion of the sleeve, which second longitudinal portion is entirely longitudinally distinct from the first longitudinal portion.

For some applications, the contracting assembly further includes a locking mechanism, and the method further includes, after contracting the at least a portion of the second longitudinal portion of the sleeve, locking the longitudinal contracting member with respect to the contracting assembly using the locking mechanism.

For some applications, contracting the at least a portion of the second longitudinal portion of the sleeve includes actuating the contracting assembly to contract the at least a portion of the second longitudinal portion of the sleeve.

There is further provided, in accordance with an application of the present invention, apparatus including an annuloplasty ring, which includes:

a flexible sleeve; and

an elongated radial-force application element, which (a) is disposed entirely within a longitudinal portion of the sleeve, (b) which has a length of no more than 6 cm, measured when the sleeve is fully longitudinally extended, and (c) is configured to apply a force against a wall of the longitudinal portion of the sleeve in at least one radially-outward direction.

For some applications, the elongated radial-force application element is rotationally asymmetric and not helically symmetric.

For some applications, the elongated radial-force application element is configured to apply the force against the wall around less than 100% of a perimeter of the wall.

For some applications, the elongated radial-force application element is configured to apply the force against the wall around less than 50% of the perimeter of the wall.

For some applications, the elongated radial-force application element is configured to apply the force with a variation of less than 20% along a length of the elongated radial-force application element.

For some applications, the sleeve has first and second sleeve ends.

For some applications, the annuloplasty ring further includes:

a first coupling element, which is coupled to the annuloplasty ring within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended; and

a second coupling element, which is configured to be coupleable to the first coupling element, and which is coupled to the annuloplasty ring within 1.5 cm of the second sleeve end, measured when the sleeve is fully longitudinally extended.

For some applications, the elongated radial-force application element has (a) a first radial-force-application-element longitudinal end that is between 2 and 6 cm from the first sleeve end, measured when the sleeve is fully longitudinally extended, and (b) a second radial-force-application-element longitudinal end that is within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended.

For some applications, the sleeve is shaped so as to define an integrally closed loop having no sleeve ends.

For some applications:

the annuloplasty ring further includes a contracting assembly, which includes a housing that is fixed to the sleeve, and

the elongated radial-force application element has (a) a first radial-force-application-element longitudinal end that is between 2 and 6 cm from the housing, measured when the sleeve is fully longitudinally extended, and (b) a second radial-force-application-element longitudinal end that is within 1.5 cm of the housing, measured when the sleeve is fully longitudinally extended.

For some applications, the elongated radial-force application element is configured to push the longitudinal portion of the sleeve against atrial tissue.

For some applications, the annuloplasty ring further includes a substantially longitudinally non-extensible linking member, which has first and second linking-member ends and is at least partially disposed within the longitudinal portion of the sleeve, and the second linking-member end includes the first coupling element.

For some applications, the linking member has a length of between 2 and 6 cm.

For some applications, at least the longitudinal portion of the sleeve is substantially longitudinally non-extensible, and the first coupling element is fixed to the wall of the sleeve within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended.

For some applications, the elongated radial-force application element includes a springy element.

For some applications, where at least a portion of the springy element is curved at least partially about an inner surface of the wall of the sleeve.

For some applications, at least a portion of the springy element is serpentine.

For some applications, the at least a portion of the springy element is curved at least partially about the inner surface of the wall in a single circumferential direction.

For some applications, at least a first portion of the springy element is curved at least partially about the inner surface of the wall in a first circumferential direction, and at least a second portion of the springy element is curved at least partially about the inner surface of the wall in a second circumferential direction circumferentially opposite the first circumferential direction.

For some applications, at least a portion of the springy element is serpentine.

For some applications, springy element includes a coiled spring.

For some applications,

the longitudinal portion of the sleeve is a first longitudinal portion of the sleeve, and

the annuloplasty ring further includes a longitudinal contracting member, which is arranged only along a second longitudinal portion of the sleeve that is entirely longitudinally distinct from the first longitudinal portion of the sleeve.

For some applications, the annuloplasty ring further includes a contracting assembly, which includes the longitudinal contracting member and a contracting mechanism.

For some applications, a first average internal diameter of the first longitudinal portion of the sleeve is greater than a second average internal diameter of the second longitudinal portion of the sleeve, when both the first and the second longitudinal portions are fully radially expanded.

For some applications, the first longitudinal portion of the sleeve is radially elastic, and the second longitudinal portion of the sleeve is substantially radially non-extensible.

For some applications, the first and the second longitudinal portions of the sleeve are substantially longitudinally non-extensible.

For some applications, the first and the second longitudinal portions of the sleeve have a same diameter when the first longitudinal portion is not elastically stretched.

For some applications, the first and the second longitudinal portions of the sleeve are woven, and the first longitudinal portion of the sleeve is more loosely woven than the second longitudinal portion of the sleeve.

For some applications, the first longitudinal portion of the sleeve is radially stretchable, and the second longitudinal portion of the sleeve is substantially radially non-extensible.

For some applications, the annuloplasty ring further includes a plurality of tissue anchors, at least two of which are coupled to the sleeve at respective, different longitudinal sites alongside the elongated radial-force application member.

For some applications, the annuloplasty ring further includes a contracting assembly, which includes a contracting mechanism and a longitudinal contracting member, and the contracting mechanism is fixed to the sleeve within 1.5 cm of the second sleeve end, measured when the sleeve is fully longitudinally extended.

For some applications, the second coupling element is coupled to the contracting mechanism.

For some applications, the longitudinal contracting member includes at least one wire.

For some applications, the elongated radial-force application member includes metal.

For some applications, the metal includes Nitinol.

For some applications, at least one of the first and second coupling elements includes a hook.

For some applications, at least one of the first and second coupling elements includes a loop.

providing an annuloplasty ring, which includes (a) a flexible sleeve and (b) an elongated radial-force application element, which is disposed entirely within a longitudinal portion of the sleeve;

during a percutaneous transcatheter procedure, placing the flexible sleeve entirely around an annulus of an atrioventricular valve of a subject, such that the longitudinal portion of the sleeve is disposed along an anterior portion of the annulus between fibrous trigones of the valve; and

fastening the flexible sleeve at least to a posterior portion of the annulus, such that the elongated radial-force application element applies a force against the wall of the longitudinal portion of the sleeve in at least one radially-outward direction.

For some applications, the flexible sleeve has first and second sleeve ends, and placing the flexible sleeve includes introducing the flexible sleeve into a left atrium while the first and the second sleeve ends are not coupled to each other; and thereafter, in the left atrium, arranging the flexible sleeve entirely around the annulus to form the closed loop.

For some applications:

the annuloplasty ring further includes (a) a first coupling element, which is coupled to the annuloplasty ring within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended, (b) a second coupling element, which is configured to be coupleable to the first coupling element, and which is coupled to the annuloplasty ring within 1.5 cm of the second sleeve end, measured when the sleeve is fully longitudinally extended, and

coupling the first and the second sleeve ends to each other to form the closed loop includes coupling the first and the second coupling elements together.

For some applications, the elongated radial-force application element has (a) a first radial-force-application-element longitudinal end that is between 2 and 6 cm from the first sleeve end, measured when the sleeve is fully longitudinally extended, and (b) a second radial-force-application-element longitudinal end that is within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended,

For some applications:

For some applications, the linking member has a length of between 2 and 6 cm.

For some applications, placing the longitudinal portion of the sleeve includes twisting the longitudinal portion of the sleeve after fastening the sleeve to the portion of the annulus.

For some applications, placing the longitudinal portion of the sleeve includes twisting the springy element after fastening the sleeve to the portion of the annulus.

For some applications, at least a portion of the springy element is serpentine.

For some applications, springy element includes a coiled spring.

For some applications, the longitudinal portion of the sleeve is a first longitudinal portion, and the method further includes, after fastening the flexible sleeve at least to a posterior portion of the annulus, contracting a second longitudinal portion of the sleeve that is entirely longitudinally distinct from the first longitudinal portion of the sleeve.

For some applications, the longitudinal portion of the sleeve is a first longitudinal portion of the sleeve, and the annuloplasty ring further includes a longitudinal contracting member, which is arranged only along a second longitudinal portion of the sleeve that is entirely longitudinally distinct from the first longitudinal portion of the sleeve.

For some applications, the annuloplasty ring further includes a contracting assembly, which includes a contracting mechanism and a longitudinal contracting member, and the contracting mechanism is fixed to the sleeve within 30 mm of the second sleeve end, measured when the sleeve is fully longitudinally extended.

For some applications, the springy member includes metal.

For some applications, the metal includes Nitinol.

There is additionally provided, in accordance with an application of the present invention, apparatus including an implantable structure, which includes:

a flexible sleeve, having first and second sleeve ends;

a contracting assembly;

an elongated linking member, having a first and second linking member ends, which second linking member end includes a first coupling element, wherein the linking member is coupled to the sleeve such that (a) at least a portion of the linking member is disposed within the sleeve, and (b) the first linking member end is longitudinally between the second linking member end and the first sleeve end, exclusive; and

a second coupling element, which is configured to be coupleable to the first coupling element, and which is coupled to the implantable structure within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended.

For some applications, the contracting assembly is configured to longitudinal contract the sleeve.

For some applications, the implantable structure further includes a plurality of tissue anchors, at least two of which are coupled to the sleeve at respective, different longitudinal sites alongside the linking member.

For some applications, the contracting assembly includes a contracting mechanism and a longitudinal contracting member, and the contracting mechanism is coupled to the sleeve within 1.5 cm of the first sleeve end.

For some applications, the linking member is configured as a spring.

For some applications, the linking member is curved.

For some applications, the linking member has a length of between 2 and 6 cm.

For some applications, the linking member includes metal.

For some applications, the metal includes Nitinol.

For some applications, at least 30% of a length of the linking member is disposed within the sleeve.

For some applications, at least 75% of the length of the linking member is disposed within the sleeve.

For some applications, the flexible sleeve is a first flexible sleeve, the implantable structure further includes a second flexible sleeve, and at least 20% of a length of the linking member is disposed within the second flexible sleeve.

For some applications, the at least a portion of the linking member is disposed within a longitudinal portion of the sleeve, and the implantable structure further includes an elongated springy element, which is disposed within the longitudinal portion of the sleeve, and which is configured to apply a force against a wall of the longitudinal portion of the sleeve in at least one radially-outward direction.

For some applications, the linking member is not configured as a spring.

For some applications, the linking member is configured not to apply any force to the wall of the longitudinal portion of the sleeve.

For some applications, the springy element has a length of between 2 and 6 cm, measured when the sleeve is fully longitudinally extended.

For some applications:

the contracting assembly includes (a) a contracting mechanism, and (b) a longitudinal contracting member, which is arranged only along a second longitudinal portion of the sleeve that is entirely longitudinally distinct from the first longitudinal portion of the sleeve, and

the springy element is disposed entirely within the first longitudinal portion of the sleeve.

For some applications, the first and the second coupling elements are configured to provide an adjustable-length connection between the linking member and the first sleeve end.

There is yet additionally provided, in accordance with an application of the present invention, a method including:

providing an implantable structure, which includes (a) a flexible sleeve, having first and second sleeve ends, (b) a contracting assembly, (c) an elongated linking member, having a first and second linking member ends, which second linking member end includes a first coupling element, wherein the linking member is coupled to the sleeve such that (i) at least a portion of the linking member is disposed within the sleeve, and (ii) the first linking member end is longitudinally between the second linking member end and the first sleeve end, exclusive, and (d) a second coupling element, which is coupled to the implantable structure within 1.5 cm of the first sleeve end, measured when the sleeve is fully longitudinally extended;

placing the linking member along an anterior portion of the annulus between fibrous trigones of the valve;

fastening the flexible sleeve to the portion of the annulus;

coupling the first and the second coupling elements together; and

contracting a longitudinal portion of the sleeve.

For some applications, contracting the second longitudinal portion of the sleeve includes actuating the contracting assembly to contract the longitudinal portion of the sleeve.

For some applications, fastening includes fastening the sleeve to the annulus using a plurality of tissue anchors, including coupling at least two of the anchors to the sleeve and tissue of the annulus at respective, different longitudinal sites alongside the linking member.

For some applications, the linking member is configured as a spring.

For some applications, the linking member is curved.

For some applications, the linking member has a length of between 2 and 6 cm.

For some applications, the linking member includes metal.

For some applications, the metal includes Nitinol.

For some applications:

the at least a portion of the linking member is disposed within a longitudinal portion of the sleeve,

the implantable structure further includes an elongated springy element, which is disposed within the longitudinal portion of the sleeve, and

placing the linking member includes placing the springy element along the anterior portion of the annulus, such that the springy element applies a force against a wall of the longitudinal portion of the sleeve in at least one radially-outward direction.

For some applications, the linking member is not configured as a spring.

For some applications:

For some applications, the first and the second coupling elements are configured to provide an adjustable-length connection between the linking member and the first sleeve end, and placing the linking member along the anterior portion of the annulus includes setting an effective length of the linking member while coupling the first and the second coupling elements together.

There is also provided, in accordance with an application of the present invention, apparatus including an annuloplasty system, which includes:

an implantable structure, which includes a flexible sleeve, having first and second sleeve ends;

a linking bridge element, which includes first and second bridge coupling interfaces, which are configured to be coupled to the sleeve in order to link the first and the second sleeve ends via the linking bridge element; and

first and second flexible longitudinal guide members, which (a) are removably coupled to the sleeve within 1.5 cm of the first and the second sleeve ends, respectively, measured when the sleeve is fully longitudinally extended, and (b) extend from the first and the second sleeve ends, respectively, away from the sleeve, and (c) removably pass through respective openings defined by the linking bridge member, so as to guide the first and the second bridge coupling interfaces to corresponding locations on the sleeve.

For some applications, the respective openings defined by the linking bridge member are defined by the first and the second bridge coupling interfaces, respectively.

For some applications, the sleeve includes first and second sleeve coupling interfaces, to which the first and the second bridge coupling interfaces are configured to be coupled, respectively.

For some applications, the first and the second sleeve coupling interfaces are disposed within 1.5 cm of the first and the second sleeve ends, respectively, measured when the sleeve is fully longitudinally extended.

For some applications, the linking bridge element has a length of between 1 and 5 cm.

For some applications, the implantable structure includes a longitudinal contracting member, which is configured to longitudinally contract a longitudinal portion of the sleeve, and the first and the second flexible longitudinal guide members are separate and distinct from the longitudinal contracting member.

For some applications, wherein, when the first and the second flexible longitudinal guide members are removably coupled to the sleeve, the first and the second flexible longitudinal guide members do not longitudinally overlap the longitudinal contracting member.

For some applications, wherein, when the first and the second flexible longitudinal guide members are removably coupled to the sleeve, no portion of either the first flexible longitudinal guide member or the second flexible longitudinal guide member is disposed more than 1.5 cm from the first and the second sleeve ends, respectively, measured when the sleeve is fully longitudinally extended.

For some applications, wherein, when the first and the second flexible longitudinal guide members are removably coupled to the sleeve, the first and the second flexible longitudinal guide members are collectively disposed along less than 30% of a length of the sleeve, measured when the sleeve is fully longitudinally extended.

during a percutaneous transcatheter procedure, placing a flexible sleeve of an implantable structure partially around an annulus of a mitral valve of a subject, such that first and second flexible longitudinal guide members, which are removably coupled to the sleeve, extend from first and second sleeve ends of the sleeve, respectively, away from the sleeve, wherein the longitudinal guide members are removably coupled to the sleeve within 1.5 cm of the first and the second sleeve ends of the sleeve, respectively, measured when the sleeve is fully longitudinally extended;

advancing a linking bridge element into a left atrium of the subject, while the longitudinal guide members removably pass through respective openings defined by the linking bridge member;

using the first and the second longitudinal guide members to guide first and second bridge coupling interfaces of the linking bridge member to corresponding locations on the sleeve; and

coupling the linking bridge member to the sleeve by coupling the first and the second bridge coupling interfaces to the sleeve, in order to link the first and the second sleeve ends via the linking bridge element.

For some applications, the sleeve includes first and second sleeve coupling interfaces, and coupling the first and the second bridge coupling interfaces to the sleeve includes coupling the first and the second bridge coupling interfaces to the sleeve to the first and the second sleeve coupling interfaces, respectively.

For some applications:

the implantable structure includes a longitudinal contracting member,

the first and the second flexible longitudinal guide members are separate and distinct from the longitudinal contracting member, and

the method further includes, after coupling the linking bridge member to the sleeve, contracting a longitudinal portion of the sleeve by causing the longitudinal contracting member to apply a contracting force to the longitudinal portion of the sleeve.

There is still further provided, in accordance with an application of the present invention, apparatus including an annuloplasty system, which includes:

an implantable structure, which includes a flexible sleeve, having first and second sleeve ends; and

first and second flexible longitudinal guide members, which (a) are removably coupled to the sleeve within 1.5 cm of the first and the second sleeve ends, respectively, measured when the sleeve is fully longitudinally extended, and (b) extend from the first and the second sleeve ends, respectively, away from the sleeve.

The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a system for repairing a dilated atrioventricular valve, such as a mitral valve, in accordance with an application of the present invention;

FIGS. 2A-I are schematic illustrations of a procedure for implanting the implantable structure ofFIG. 1 to repair a mitral valve, in accordance with an application of the present invention;

FIG. 3 is a schematic illustration of another configuration of the implantable structure ofFIG. 1, prior to implantation, in accordance with an application of the present invention;

FIG. 4 is a schematic illustration of the implantable structure ofFIG. 3 after implantation around the annulus of a mitral valve, in accordance with an application of the present invention;

FIG. 5 is a schematic illustration of a closed-loop configuration of the implantable structure ofFIG. 1, in accordance with an application of the present invention;

FIG. 6 is a schematic illustration of yet another configuration of the implantable structure ofFIG. 1, prior to implantation, in accordance with an application of the present invention;

FIGS. 7A-B are schematic illustrations of the implantable structure ofFIG. 6 after implantation around the annulus of a mitral valve, in accordance with respective applications of the present invention;

FIGS. 8A-D are schematic illustrations of coupling elements, in accordance with respective applications of the present invention;

FIG. 9 is a schematic illustration of another configuration of the implantable structure ofFIG. 1, prior to implantation, further comprising an elongated radial-force application element, in accordance with an application of the present invention;

FIG. 10 is a schematic illustration of the implantable structure ofFIG. 9 implanted around the mitral valve, in accordance with an application of the present invention;

FIGS. 11A-D are schematic illustrations of several configurations of the elongated radial-force application element of the implantable structure ofFIGS. 9 and 10, in accordance with an application of the present invention;

FIG. 12 is a schematic illustration of another configuration of the elongated radial-force application element of the implantable structure ofFIGS. 9 and 10, in accordance with an application of the present invention;

FIG. 13 is a schematic illustration of yet another configuration of the elongated radial-force application element of the implantable structure ofFIGS. 9 and 10, in which the elongated radial-force application element is helically symmetric, in accordance with an application of the present invention;

FIG. 14 is a schematic illustration of a configuration of the sleeve of the implantable structure ofFIGS. 9 and 10, in accordance with an application of the present invention;

FIG. 15 is a schematic illustration of another configuration of the implantable structure ofFIGS. 9 and 10, in accordance with an application of the present invention;

FIGS. 16A-B are schematic illustrations of another configuration of the implantable structure ofFIGS. 9 and 10, in which the sleeve is shaped so as to define an integrally closed loop having no sleeve ends, in accordance with an application of the present invention;

FIG. 17 is a schematic illustration of another configuration of the implantable structure ofFIG. 9 implanted around the mitral valve, in accordance with an application of the present invention

FIGS. 18A and 18B are schematic illustrations of yet another configuration of the implantable structure ofFIG. 1, prior to implantation and upon implantation around the mitral valve, respectively, in accordance with an application of the present invention;

FIG. 19 is a schematic illustration of still another configuration of the implantable structure ofFIG. 1 implanted around the mitral valve, in accordance with an application of the present invention;

FIG. 20 is a schematic illustration of another configuration of the implantable structure ofFIG. 1 implanted around the mitral valve, in accordance with an application of the present invention;

FIG. 21 is a schematic illustration of still another configuration of the implantable structure ofFIG. 1 implanted around the mitral valve, in accordance with an application of the present invention;

FIGS. 22A-D are schematic illustrations of another system for repairing a dilated atrioventricular valve, and a method for deploying the system, in accordance with an application of the present invention;

FIGS. 23A-B are schematic illustrations of another configuration of a linking bridge element of the system ofFIGS. 22A-D, in accordance with an application of the present invention;

FIG. 24 is a schematic illustration of a contracting mechanism, disassembled to show a relationship among individual components of the contracting mechanism, in accordance with an application of the present invention; and

FIGS. 25A-B and26 are schematic illustrations of a valve prosthesis assembly, in accordance with respective applications of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

FIG. 1 is a schematic illustration of asystem20 for repairing a dilated atrioventricular valve, such as a mitral valve or a tricuspid valve, in accordance with an application of the present invention.System20 comprises an adjustableimplantable structure22, shown inFIG. 1 in a straight, relaxed, non-contracted state, and an anchor deployment manipulator24 (shown inFIGS. 2G-H). For some applications,implantable structure22 is configured to be deployed as an annuloplasty ring, while for other applications,implantable structure22 is configured to be deployed as a base ring to which a prosthetic valve is coupled, such as described hereinbelow with reference toFIGS. 25A-B or26.Implantable structure22 comprises aflexible sleeve26.Anchor deployment manipulator24 is advanced intosleeve26, as shown inFIGS. 2G-H, and, from within the sleeve, deploys tissue anchors through a wall of the sleeve into cardiac tissue, thereby anchoring the ring around at least a portion of the valve annulus. For some applications, anchor deployment manipulator is implemented using techniques described in US Patent Application Publication 2010/0280604, which is incorporated herein by reference, with reference toFIGS. 2, 3, 4, 5A, 5B, 6A, 6B, 7, 8, 13, and/or20A-E thereof.

For some applications,implantable structure22 comprises a partial annuloplasty ring. In these applications,sleeve26 is configured to be placed only partially around the valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. For other applications,sleeve26 is configured to be implanted entirely around the valve annulus in a closed loop, such as described hereinbelow with reference toFIG. 4, 5, 7A-B,10,16A-B,17 or18B.

Implantable structure

22 further comprises acontracting assembly40, which facilitates contracting of the implantable structure.Contracting assembly40 typically comprises acontracting mechanism28, and alongitudinal contracting member30, which is coupled tocontracting mechanism28, extends along a portion of the sleeve, and is typically flexible. For example, contractingmember30 may comprise at least one wire.Contracting assembly40 is configured to contract a longitudinal portion ofsleeve26, and is described in more detail hereinbelow. In addition, the implantable structure typically comprises a plurality of tissue anchors38, typically between about 5 and about 20 anchors, such as about 10 or about 16 anchors. InFIG. 1, anchors38 are shown coupled toimplantable structure22, deployed through the wall ofsleeve26. For some applications, anchors38 are configured as described with reference toFIGS. 5A-C,5D,5E,5F,5G,5H, and/or5I in US Patent Application Publication 2012/0330411, which is incorporated herein by reference, while for other applications, anchors38 comprise tissue anchors known in the art.

Flexible sleeve

26 may comprise a braided, knitted, or woven mesh or a tubular structure comprising ePTFE. For some applications, the braid comprises metal and fabric fibers. The metal fibers, which may comprise Nitinol for example, may help define the shape of the sleeve, e.g., hold the sleeve open to provide space for passage and manipulation ofdeployment manipulator24 within the sleeve. The fabric fibers may promote tissue growth into the braid. Typically,sleeve26 is substantially longitudinally non-extensible, i.e., a length thereof is substantially constant, i.e., cannot be longitudinally stretched, under normal usage conditions. Alternatively, the sleeve is somewhat elastic, which gives the sleeve a tendency to longitudinally contract, thereby helping tighten the sleeve. For example, the sleeve may be bellows- or accordion-shaped.

For some applications, the sleeve is configured to have a tendency to assume a straight shape when in its relaxed, non-contracted state. This straightness may help the surgeon locate the next site for each subsequent anchor during the implantation procedure. For example, because the sleeve assumes a generally straight shape, the sleeve may help provide an indication of distance between adjacent anchoring sites. For some applications, the sleeve is configured to have a controllably variable stiffness. For example, a somewhat stiff wire may be placed in the sleeve to provide the stiffness, and subsequently be removed at the conclusion of the implantation procedure when the stiffness is no longer useful.

For some applications,sleeve26 comprises a plurality ofradiopaque markers39, which are positioned along the sleeve at respective longitudinal sites. The markers may provide an indication in a radiographic image (such as a fluoroscopy image) of how much of the sleeve has been deployed at any given point during an implantation procedure, in order to enable setting a desired distance betweenanchors38 along the sleeve. For some applications, the markers comprise a radiopaque ink.

Typically, at least a portion (e.g., at least three, such as all) of the longitudinal sites are longitudinally spaced at a constant interval. Typically, the longitudinal distance between the distal edges of adjacent markers, and/or the distance between the proximal edges of adjacent markers, is set equal to the desired distance between adjacent anchors. For example, the markers may comprise first, second, and third markers, which first and second markers are adjacent, and which second and third markers are adjacent, and the distance between the proximal and/or distal edges of the first and second markers equal the corresponding distance between the proximal and/or distal edges of the second and third markers. For example, the distance may be between 3 and 15 mm, such as 6 mm, and the longitudinal length of each marker may be between 0.1 and 14 mm, such as 2 mm. (If, for example, the distance were 6 mm and the length were 2 mm, the longitudinal gaps between adjacent markers would have lengths of 4 mm.)

Longitudinal contracting member

30 comprises a wire, a ribbon, a rope, or a band, which typically comprises a flexible and/or superelastic material, e.g., nitinol, polyester, HDPE, stainless steel, or cobalt chrome. For some applications, the wire comprises a radiopaque material. For some applications,longitudinal contracting member30 comprises a braided polyester suture (e.g., Ticron). For some applications,longitudinal contracting member30 is coated with polytetrafluoroethylene (PTFE). For some applications, contractingmember30 comprises a plurality of wires that are intertwined to form a rope structure. For some applications,implantable structure22 comprises a plurality ofcontracting members30, which may extend along generally the same longitudinal portion ofsleeve26, or along respective, different portions of sleeve26 (e.g., as described with reference toFIG. 13 in above-mentioned US Patent Application Publication 2012/0330411).

For some applications, contractingmember30 is positioned at least partially within a lumen of thesleeve26, such as entirely within the lumen (as shown inFIGS. 1, 2H-I,3,4,6, and7A-B). For some applications in which the contracting member is positioned partially within the lumen, the contracting member is sewn into the wall of the sleeve, such that the contracting member is alternatingly inside and outside of the sleeve along the length of the sleeve (configuration not shown). Optionally,sleeve26 defines an internal channel within whichmember30 is positioned (configuration not shown). Alternatively, the contracting member is disposed outside the lumen of the sleeve, such as alongside an outer wall of the sleeve. For example,sleeve26 may define an external channel within whichcontracting member30 is positioned, or the sleeve may comprise or be shaped so as to define external coupling elements, such as loops or rings (configuration not shown). For some applications, contractingmember30 is positioned approximately opposite the anchors.

For some applications of the present invention,contracting mechanism28 comprises a rotatable structure, such as aspool46. The rotatable structure is arranged such that rotation thereof applies a longitudinal contracting force, thereby contracting at least a longitudinal portion ofimplantable structure22. Typically, in these applications,contracting mechanism28 further comprises ahousing44 in which the rotatable structure, e.g., the spool, is positioned. Contractingmember30 has first and second member ends, and a first member end portion, which extends from the first member end toward the second member end along only a longitudinal portion of the contracting member. For some applications, the first member end portion, e.g., the first member end of contractingmember30, is coupled tocontracting mechanism28, such as the rotatable structure, e.g., the spool (alternatively, although the first member end portion is coupled to the contracting mechanism, the first member end protrudes beyond the contracting mechanism). For example,spool46 may be shaped to provide a hole42 or other coupling mechanism for coupling the first end of contractingmember30 to the spool, and thereby tocontracting mechanism28.Contracting assembly40 is arranged such that rotation of the spool winds a portion of the contracting member around the spool. Alternatively, contractingmember30 may comprise at least one wire (e.g., exactly one wire) that passes through a coupling mechanism ofspool46, in order to couple the wire to the spool. The ends of the wire are brought together, and together serve as asecond end53 of contractingmember30. In this configuration, approximately the longitudinal center of the wire serves as the first end of the contracting member.

Alternatively,contracting mechanism28 may comprise a ratchet contracting mechanism, which typically comprises a ratchet-coupling housing. Contractingmember30 is shaped so as to define engaging structures, such as grooves or teeth. Techniques may be used that are described in International Application PCT/IL2009/000593, filed Jun. 15, 2009, which published as PCT Publication WO 10/004546, and in U.S. application Ser. No. 12/996,954, which published as US Patent Application Publication 2011/0166649, in the national stage thereof, all of which applications and publications are incorporated herein by reference.

Further alternatively,contracting mechanism28 may comprise a housing or other structure (e.g., a ring or an eyelet) which is shaped so as to define an opening therethrough. Contractingmember30 is drawn through the opening (such that the first member end protrudes beyond the opening), and, once a desired length has been achieved, is locked, such as using a locking bead, or by crimping or knotting.

Contractingmember30 extends along less than the entire length ofsleeve26. Contracting mechanism28 (e.g.,housing44 thereof) is disposed at afirst site34 ofsleeve26 that is a first longitudinal distance D1 from a first end of the sleeve, either aproximal end49 ofsleeve26, as shown inFIG. 1, or adistal end51 ofsleeve26, as shown inFIGS. 2G-I. (Longitudinal distance D1 is measured between the first end of the sleeve and the portion ofcontracting mechanism28 that is closest to the first end.) For some applications,second end53 of contractingmember30 is coupled to the sleeve at asecond site36 that is a second longitudinal distance D2 from a second end of the sleeve, which second end is longitudinally opposite the first end of the sleeve. For applications in whichcontracting mechanism28 comprises a rotatable structure, rotation of the rotatable structure, such asspool46, longitudinally contracts at least a portion of the sleeve, such as by winding a portion of the contracting member around the spool, thereby pulling the far end of the implantable structure toward the spool and shortening and tightening the implantable structure. Such rotation of the rotatable structure, or other actuation of contractingassembly40, typically applies a longitudinal contracting force only between first and

second sites

34 and36, which longitudinally contracts at least a portion, e.g. all, of the sleeve only between first and

second sites

34 and36. (For example, the longitudinal force may longitudinally contract less than the entire sleeve between first and

second sites

34 and36 in applications in whichsystem20 comprises coiled element240, which provides a contraction-restricting portion of the sleeve, as described hereinbelow with reference toFIGS. 10A-E and/or11A-E in above-mentioned US Patent Application Publication 2012/0330411.) Therefore, the portions of the sleeve beyond first andsecond sites34 and36 (towards the ends of the sleeve) are not contracted by contractingassembly40.

Typically, contractingmember30 extends along (i.e., a distance along the sleeve between first and

second sites

34 and36 equals) no more than 80% of the length of the sleeve, e.g., no more than 60% or no more than 50% of the length. Typically, contractingmember30 extends along no more than 80% of a circumference of the loop when the sleeve is placed around the annulus (i.e., the total length of the loop less the length of any overlapping portion). Typically, contractingmember30 extends along (i.e., a distance along the sleeve between first and

second sites

34 and36 equals) at least 20% of the length of the sleeve, e.g., at least than 40% or at least than 50% of the length. Typically, contractingmember30 extends along at least 20% of the circumference of the loop when the sleeve is placed around the annulus, e.g., at least 30% or at least 50%.

For some applications, first longitudinal distance D1, measured whensleeve26 is in a straight, relaxed, non-contracted state, is at least 3 mm, e.g., at least 5 mm, such as at least 9 mm, e.g., at least 14 mm; no greater than 20 mm, such as no greater than 15 mm; and/or between 5 and 20 mm, such as between 9 and 15 mm. Alternatively or additionally, for some applications, second longitudinal distance D2, measured whensleeve26 is in a straight, relaxed, non-contracted state, is at least 3 mm, e.g., at least 5 mm, such as at least 9 mm, e.g., at least 14 mm; no greater than 20 mm, such as no greater than 15 mm; and/or between 5 and 20 mm, such as between 9 and 15 mm. Further alternatively or additionally, first longitudinal distance D1, measured whensleeve26 is in a straight, relaxed, non-contracted state, is no greater than 20%, such as no greater than 10% of a total length of the sleeve, measured whensleeve26 is in a straight, relaxed, non-contracted state. Further alternatively or additionally, second longitudinal distance D2, measured whensleeve26 is in a straight, relaxed, non-contracted state, is no greater than 30%, such as no greater than 20%, e.g., no greater than 10% of the total length of the sleeve measured, whensleeve26 is in a straight, relaxed, non-contracted state. For some applications, the total length of the sleeve, measured when the sleeve is in a straight, relaxed, non-contracted state is at least 5 cm, no more than 25 cm, and/or between 5 and 25 cm. For some applications in which the sleeve is implanted in a closed loop, the total length of the sleeve is selected to be between 1.3 and 1.4 times a circumference of the annulus, in order to provide overlapping portion114, described hereinbelow with reference toFIGS. 3 and 4.

For some applications, at least one of tissue anchors38 (e.g., exactly one, at least two, exactly two, at least three, exactly three, or at least four, or no more than four) is coupled tosleeve26 longitudinally between contracting mechanism28 (e.g.,housing44 thereof) and the first sleeve end (i.e., the end of the sleeve to whichcontracting mechanism28 is closest), exclusive, and at least 3, such as at least 6, of tissue anchors38 are coupled to the sleeve alongside contractingmember30, longitudinally betweenfirst site34 and second site36 (second member end53), exclusive. (As used in the present application, including in the claims, “exclusive,” when used with respect to a range of locations, means excluding the endpoints of the range.)

Alternatively or additionally, for some applications, at least one of tissue anchors38 (e.g., exactly one, at least two, exactly two, at least three, exactly three, or at least four, or no more than four) is coupled tosleeve26 longitudinally between second site36 (second member end53) and the second sleeve end (i.e., the end of the sleeve to whichsecond member end53 is closest), exclusive, and at least 3, such as at least 6, of tissue anchors38 are coupled to the sleeve alongside contractingmember30, longitudinally betweenfirst site34 and second site36 (second member end53), exclusive.

In the exemplary configuration shown inFIG. 1, exactly two tissue anchors38 are coupled to the sleeve longitudinally between the contracting mechanism (e.g., the housing) (first site34) and the first sleeve end, exclusive, exactly two tissue anchors are coupled to the sleeve longitudinally betweenfirst site34 and second site36 (second member end53), exclusive, and exactly six tissue anchors38 are coupled to the sleeve alongside the contracting member, longitudinally betweenfirst site34 and second site36 (second member end53), exclusive.

Providing the one or more anchors beyond first andsecond sites34 and36 (i.e., beyond the contracting portion of contracting member30) generally distributes force applied by contraction of contractingassembly40 over these anchors. In contrast, in some configurations ofimplantable structure22 in which anchors are not provided beyond first and

second sites

34 and36, the force applied by the contracting assembly is applied predominantly to the single anchor nearest the first end of the contracting member, and the single anchor nearest to second end of the contracting member.

For some applications, anchors38 are positioned alongsleeve26 with a longitudinal distance of between 4.5 and 9 mm, such as 6 mm, between each pair of longitudinally-adjacent anchors.

It is noted that the anchors may be positioned as described above by a surgeon during an implantation procedure, such as described hereinbelow with reference toFIGS. 2A-I, or the anchors may be prepositioned in the sleeve.

Reference is now made toFIGS. 2A-I, which are schematic illustrations of a procedure for implantingimplantable structure22 to repair amitral valve130, in accordance with an application of the present invention. The procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography.

The procedure typically begins by advancing asemi-rigid guidewire102 into aright atrium120 of the patient, as shown inFIG. 2A.

As shown inFIG. 2B, guidewire102 provides a guide for the subsequent advancement of asheath104 therealong and into the right atrium. Oncesheath104 has entered the right atrium, guidewire102 is retracted from the patient's body.Sheath104 typically comprises a 14-20 F sheath, although the size may be selected as appropriate for a given patient.Sheath104 is advanced through vasculature into the right atrium using a suitable point of origin typically determined for a given patient. For example:

- sheath104 may be introduced into the femoral vein of the patient, through aninferior vena cava122, intoright atrium120, and into aleft atrium124 transseptally, typically through the fossa ovalis;
- sheath104 may be introduced into the basilic vein, through the subclavian vein to the superior vena cava, intoright atrium120, and intoleft atrium124 transseptally, typically through the fossa ovalis; or
- sheath104 may be introduced into the external jugular vein, through the subclavian vein to the superior vena cava, intoright atrium120, and intoleft atrium124 transseptally, typically through the fossa ovalis.

For some applications,sheath104 is advanced through aninferior vena cava122 of the patient (as shown) and intoright atrium120 using a suitable point of origin typically determined for a given patient.

Sheath

104 is advanced distally until the sheath reaches the interatrial septum.

As shown inFIG. 2D, aresilient needle106 and a dilator (not shown) are advanced throughsheath104 and into the heart. In order to advancesheath104 transseptally intoleft atrium124, the dilator is advanced to the septum, andneedle106 is pushed from within the dilator and is allowed to puncture the septum to create an opening that facilitates passage of the dilator and subsequentlysheath104 therethrough and intoleft atrium124. The dilator is passed through the hole in the septum created by the needle. Typically, the dilator is shaped to define a hollow shaft for passage alongneedle106, and the hollow shaft is shaped to define a tapered distal end. This tapered distal end is first advanced through the hole created byneedle106. The hole is enlarged when the gradually increasing diameter of the distal end of the dilator is pushed through the hole in the septum.

The advancement ofsheath104 through the septum and into the left atrium is followed by the extraction of the dilator andneedle106 from withinsheath104, as shown inFIG. 2E.

As shown inFIG. 2F, implantable structure22 (withanchor deployment manipulator24 therein) is advanced throughsheath104 intoleft atrium124.

As shown inFIG. 2G,distal end51 ofsleeve26 is positioned in a vicinity of a leftfibrous trigone142 of anannulus140 ofmitral valve130. (It is noted that for clarity of illustration,distal end51 ofsleeve26 is shown schematically in the cross-sectional view of the heart, although leftfibrous trigone142 is in reality not located in the shown cross-sectional plane, but rather out of the page closer to the viewer.) Alternatively, the distal end is positioned in a vicinity of a rightfibrous trigone144 of the mitral valve (configuration not shown). Further alternatively, the distal end of the sleeve is not positioned in the vicinity of either of the trigones, but is instead positioned elsewhere in a vicinity of the mitral valve, such as in a vicinity of the anterior or posterior commissure. Still further alternatively, for some applications, the distal end is positioned along an anterior portion of the annulus, such as described hereinbelow with reference toFIG. 4. For some applications, outer tube66 ofanchor deployment manipulator24 is steerable, as is known in the catheter art, while for other applications, a separate steerable tube is provided, such as described in the above-mentioned '604 publication, with reference toFIG. 15 andFIG. 16 thereof. In either case, the steering functionality typically allows the area near the distal end of the deployment manipulator to be positioned with six degrees of freedom. Once positioned at the desired site near the selected trigone,deployment manipulator24 deploys afirst anchor38 through the wall ofsleeve26 into cardiac tissue near the trigone.

As shown inFIG. 2H,deployment manipulator24 is repositioned alongannulus140 to another site selected for deployment of asecond anchor38. Typically, the first anchor is deployed most distally in the sleeve (generally at or within a few millimeters of the distal end of the sleeve), and each subsequent anchor is deployed more proximally, such that the sleeve is gradually pulled off (i.e., withdrawn from) the deployment manipulator in a distal direction during the anchoring procedure. The already-deployedfirst anchor38 holds the anchored end ofsleeve26 in place, so that the sleeve is drawn from the site of the first anchor towards the site of the second anchor. Typically, as the sleeve is pulled off (i.e., withdrawn from) the deployment manipulator, the deployment manipulator is moved generally laterally along the cardiac tissue, as shown inFIG. 2H.Deployment manipulator24 deploys the second anchor through the wall of the sleeve into cardiac tissue at the second site. Depending on the tension applied between the first and second anchor sites, the portion ofsleeve26 therebetween may remain tubular in shape, or may become flattened, which may help reduce any interference of the implantable structure with blood flow.

For some applications, in order to provide the second and subsequent anchors,anchor driver68 is withdrawn from the subject's body via sheath104 (typically while leaving outer tube66 of the deployment manipulator in place in the sleeve), provided with an additional anchor, and then reintroduced into the subject's body and into the outer tube. Alternatively, the entire deployment manipulator, including the anchor driver, is removed from the body and subsequently reintroduced upon being provided with another anchor. Further alternatively,deployment manipulator24 is configured to simultaneously hold a plurality of anchors, and to deploy them one at a time at the selected sites.

As shown inFIG. 2I, the deployment manipulator is repositioned along the annulus to additional sites, at which respective anchors are deployed, until the last anchor is deployed in a vicinity of right fibrous trigone144 (or leftfibrous trigone142 if the anchoring began at the right trigone), thereby fasteningsleeve26 andimplantable structure22 to the annulus. Alternatively, the last anchor is not deployed in the vicinity of a trigone, but is instead deployed elsewhere in a vicinity of the mitral valve, such as in a vicinity of the anterior or posterior commissure.

For applications in whichcontracting mechanism28 comprisesspool46, a rotation tool is typically used to rotatespool46 ofcontracting mechanism28, in order to tightenimplantable structure22. For some applications, the rotation tool is used that is described and shown in the above-mentioned '604 publication, with reference toFIGS. 6A-B,7, and8 thereof. As described therein,contracting mechanism28 compriseslongitudinal member86 that is attached to the contracting mechanism and passes out of the body of the subject, typically viasheath104. In order to readily bring the rotation tool to a driving interface ofcontracting mechanism28, the rotation tool is guided overlongitudinal member86. For some applications,spool46 is configured as described in the '604 publication with reference toFIGS. 1-4, 6A-B,7, and/or8 thereof.

Contracting assembly

40 typically comprises a locking mechanism that locks contractingmember30 with respect to contractingassembly40, thereby preventing loosening (and typically tightening) of contractingmember30. For some applications,spool46 comprises the locking mechanism that prevents rotation of the spool after contractingmember30 has been tightened. For example, locking techniques may be used that are described and shown in US Application Publication 2010/0161047, which is incorporated herein by reference, with reference toFIG. 4 thereof, and/or with reference toFIGS. 6B, 7, and 8 of the above-mentioned '604 publication. Alternatively, for some applications,contracting mechanism28 is configured to tighten contractingmember30, crimp the contracting member to hold the contracting member taut, and subsequently cut the excess length of the contracting member.

For some applications, a rotation handle is used to tighten the implantable structure, such as described and shown in the above-mentioned '604 publication, with reference toFIGS. 9A-C and10A-D thereof. As mentioned above, deploying the one or more anchors beyond the contracting portion of contractingmember30 generally distributes force applied by contraction of contractingassembly40 over these anchors.

For some applications,sleeve26 is filled with a material (e.g., polyester, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or expanded polytetrafluoroethylene (ePTFE)) after being implanted. The material is packed within at least a portion, e.g., 50%, 75%, or 100%, of the lumen ofsleeve26. The filler material functions to prevent (1) formation within the lumen ofsleeve26 of clots or (2) introduction of foreign material into the lumen which could obstruct the sliding movement of contractingmember30.

For some applications,proximal end49 ofsleeve26 is closed upon completion of the implantation procedure. Alternatively, the proximal end of the sleeve may have a natural tendency to close when not held open bydeployment manipulator24.

For some applications, following initial contraction ofimplantable structure22 during the implantation procedure, the structure may be further contracted or relaxed at a later time after the initial implantation, such as between several weeks and several months after the initial implantation. Using real-time monitoring and tactile feedback, optionally in combination with fluoroscopic imaging, a rotation tool or anchor driver of a deployment manipulator may be reintroduced into the heart and used to contract or relaximplantable structure22.

Reference is now made toFIGS. 3 and 4, which are schematic illustrations of another configuration ofimplantable structure22, in accordance with an application of the present invention.FIG. 3 showsimplantable structure22 in a straight, relaxed, non-contracted state, prior to implantation.FIG. 4 shows the implantable structure after implantation around the annulus ofmitral valve130, in accordance with an application of the present invention.

In this configuration,sleeve26 is implanted in a closed loop. More particularly, afirst portion110 ofsleeve26 longitudinally extends from the first sleeve end (i.e., the end of the sleeve to whichcontracting mechanism28, e.g.,housing44 thereof, is closest) towardcontracting mechanism28, e.g.,housing44 thereof (but typically does not extend all of the way to the contracting mechanism), and asecond portion112 of the sleeve longitudinally extends from the second sleeve end (i.e., the end of the sleeve to whichsecond member end53 is closest) toward second member end53 (but typically does not extend all of the way to the second member end). As shown inFIG. 4, once implanted,sleeve26 is arranged in a closed loop, such that first and

second portions

110 and112 of the sleeve together define a longitudinally overlapping portion114 of the sleeve. The overlapping portion typically has a length of at least 2 mm (e.g., at least 5 mm), no more than 60 mm (e.g., no more than 50 mm), and/or between 2 mm (e.g., 5 mm) and 60 mm (e.g., 50 mm), and/or a length that is at least 1% of a total length of the sleeve, no more than 40% of the total length (e.g., no more than 30%), and/or between 1% and 40% (e.g., 30%) of the total length of the sleeve, measured when the sleeve is in a straight, relaxed, non-contracted state.

For some applications, at least one of tissue anchors38 (labeled as38E inFIGS. 3 and 4) penetrates both first and

second portions

110 and112 of the sleeve at overlapping portion114. Such a mutual anchor helps ensure that the first and second portions remain tightly coupled together and to the tissue, so that the sleeve retains its closed loop shape. For some applications in which tissue anchor38E comprises a coupling head and a tissue coupling element, such as described hereinbelow with reference toFIG. 5D, 5E, 5F, 5G, or5I in above-mentioned US Patent Application Publication 2012/0330411, the tissue coupling element penetrates both first and

second portions

110 and112 of the sleeve at overlapping portion114, and the coupling head is positioned within one of first and

second portions

110 and112 of the sleeve at the overlapping portion. For example, in the deployment configuration shown inFIG. 4, the coupling head ofanchor38E is positioned withinsecond portion112.

This configuration ofimplantable structure22 may be implanted using the procedure described hereinabove with reference toFIGS. 2A-I, with the following differences. Unlike in the deployment shown inFIGS. 2G-I, in thisconfiguration sleeve26 is deployed as a closed band around the entire annulus of the native valve, including ananterior portion116 of the annulus (on the aortic side of the valve) between

fibrous trigones

142 and144. Typically, both first and

second portions

110 and112 of sleeve26 (and thus overlapping portion114) are positioned alonganterior portion116 of the annulus.

For some applications, during the implantation procedure, the first sleeve end (i.e., the end of the sleeve to whichcontracting mechanism28, e.g.,housing44 thereof, is closest) is placed along at least a portion ofanterior portion116 andfirst portion110 is extended along this portion. At least oneanchor38D is deployed through the wall offirst portion110 ofsleeve26 into cardiac tissue at the anterior portion of the annulus.Additional anchors38A and/or38C are deployed through the wall of the sleeve around the non-anterior remainder of the annulus, including the posterior portion thereof, as described hereinabove with reference toFIG. 2H. (Anchors38C, if provided, are deployed beyond the ends of the contracting portion of contractingmember30, whileanchors38A are deployed along the portion of the sleeve including the contracting portion of the contracting member.)

A portion of the sleeve is placed on at least a portion ofanterior portion116 of the annulus, and, typically, one ormore anchors38B are deployed through the wall of the sleeve into tissue at the anterior portion of the annulus.

The sleeve is further extended around the annulus untilsecond portion112 overlaps with previously-deployedfirst portion110 at overlapping portion114, forming a complete ring. At least oneanchor38E is deployed from withinsecond portion112 through the wall of the sleeve and into the cardiac tissue, typically atanterior portion116 of the annulus, or at a portion of the annulus nearanterior portion116. Typically,anchor38E is deployed such that it additionally passes through previously-deployed first portion110 (passing through the wall offirst portion110 twice). (Optionally, anchors38B and/or38E are of a different configuration than

anchors

38A,38C, and/or38D, such as described with reference toFIGS. 5A-I in above-mentioned US Patent Application Publication 2012/0330411; anchors38B and38E may be of the same configuration as one another, or of different configurations.)

Alternatively, the second sleeve end (i.e., the end of the sleeve to whichsecond member end53 is closest) is first placed at least partially alonganterior portion116, in which casesecond portion112 is deployed beforefirst portion110, andanchor38E is deployed from withinfirst portion110.

The sleeve may be deployed in either a clockwise direction or a counterclockwise direction, as viewed from the atrium.

Contracting assembly

40 is actuated, e.g., the rotatable structure ofcontracting mechanism28 is rotated, in order to tightenimplantable structure22, as described hereinabove with reference toFIG. 2I. Typically, contractingmember30 does not extend along the portion ofsleeve26 deployed alonganterior portion116 of the annulus, and thus does not extend alongfirst portion110,second portion112, or overlapping portion114 ofsleeve26. The portion of the sleeve deployed alonganterior portion116 of the annulus (between the trigones) is thus non-contractible. For some applications, contractingmember30 is positioned along a non-anterior portion of the annulus, which non-anterior portion does not reach either of the fibrous trigones, e.g., does not reach within 5 mm of either of the trigones. Tightening ofimplantable structure22 therefore tightens at least a portion of the posterior portion of the annulus, while preserving the length ofanterior portion116 of the annulus. (The anterior portion of the annulus should generally not be contracted because its tissue is part of the skeleton of the heart.) However, the portion of the sleeve deployed along the anterior portion of the annulus prevents dilation of the anterior annulus, because the sleeve is anchored at both ends of the anterior annulus, and, as mentioned above, the sleeve typically comprises a longitudinally non-extensible material. This deployment configuration may help prevent long-term resizing of the anterior annulus, which sometimes occurs after implantation of partial annuloplasty rings, such as C-bands.

For some applications, the non-contractible portion of sleeve26 (the portion without contracting member30) extends somewhat beyond one or both oftrigones142 or144 (in the posterior direction, away fromanterior portion116 of the annulus), such as up to 20 mm, such as up to 10 mm. In general, since the non-contractible portions of the sleeve are preset, the surgeon is able to decide during the implantation procedure the lengths of the anterior non-contractible area and the posterior contractible area, by selecting the length of overlapping portion114. The greater the length of overlapping portion114, the greater the relative length of the posterior contractible portion, and the lesser the relative length of the non-contractible portion.

For some applications, at least oneanchor38C is coupled to cardiac tissue on the posterior side of rightfibrous trigone144, between the trigone and the end of contractingmember30. Similarly, at least oneanchor38C may be coupled to cardiac tissue on the posterior side of leftfibrous trigone142, between the trigone and the other end of contracting member30 (which, for some applications, is coupled tocontracting mechanism28, as shown inFIG. 4).

For some applications, at least one (either one or both) of first and second longitudinal distances D1 and D2 (described hereinabove with reference toFIG. 1), taken separately, is greater than 40 mm, such as greater than 60 mm. This sleeve portion(s) beyond the contracting portion of contractingmember30 provide the non-contractible portion of the sleeve positioned alonganterior portion116 of the annulus, and, optionally, the non-contractible portion(s) that extend beyond the anterior portion.

Reference is still made toFIGS. 3 and 4. For some applications, anchors38 deployed alonganterior portion116 of the annulus (between the trigones) are of a different configuration fromanchors38 deployed along the remainder of the annulus (including the posterior portion of the annulus). Unlike the remainder of the annulus,anterior portion116 does not comprise muscular or fibrous tissue, but rather thinner aortic tissue (typically the anchors positioned alonganterior portion116 enter the aorta below the aortic leaflets). The anchors that are deployed along the remainder of the annulus are configured for strong coupling to the thicker and stronger fibrous tissue of these portions of the annulus. Such anchors may be inappropriate for coupling toanterior portion116.Anchors38 are thus provided that are particularly configured for coupling toanterior portion116. For example, different configurations ofanchors38 are described with reference toFIGS. 5A-I in above-mentioned US Patent Application Publication 2012/0330411.

For these applications, anchors38 include a plurality of first tissue anchors of a first configuration, and a plurality of second tissue anchors of a second configuration different from the first configuration. (The first tissue anchors are labeled38A and38C inFIG. 4, and for the sake of brevity, are referenced as38A hereinbelow. The second tissue anchors are labeled38B,38D, and38E inFIG. 4, and for the save of brevity, are referenced as38B hereinbelow.) For some applications,implantable structure22 comprises more first tissue anchors38A than second tissue anchors38B, e.g., at least twice as many first tissue anchors as second tissue anchors.

For these applications,sleeve26 is typically arranged as a loop. For example, as described hereinabove with reference toFIG. 4, the sleeve may be shaped so as to define first and second sleeve ends, which are coupled to each other (optionally, with overlapping portion114) to form the loop. Alternatively, as described hereinbelow with reference toFIG. 6, the sleeve may be shaped so as to define an integrally closed loop having no sleeve ends. First tissue anchors38A are coupled tosleeve26 at intervals along a first longitudinally-contiguous portion of the loop, and second tissue anchors38B are coupled tosleeve26 at intervals along a second longitudinally-contiguous portion of the loop different from the first longitudinally-contiguous portion. The second portion of the loop is deployed alonganterior portion116 of the annulus, and the first portion of the loop is deployed along at least a portion of the remainder of the annulus (including the posterior portion of the annulus).

Reference is made toFIG. 5, which is a schematic illustration of an alternative closed-loop configuration ofimplantable structure22, in accordance with an application of the present invention. In this configuration,flexible sleeve26 is shaped so as to define an integrally closed loop having no sleeve ends. For some applications, anchors38 deployed alonganterior portion116 of the annulus are of a different configuration fromanchors38 deployed along the remainder of the annulus, as described hereinabove with reference toFIGS. 3-4. The anchors may be configured as described with reference toFIGS. 5A-I in above-mentioned US Patent Application Publication 2012/0330411.

Typically, contractingmember30 does not extend along the portion ofsleeve26 deployed alonganterior portion116 of the annulus. The portion of the sleeve deployed alonganterior portion116 of the annulus (between the trigones) is thus non-contractible. Tightening ofimplantable structure22 therefore tightens at least a portion of the posterior portion of the annulus, while preserving the length ofanterior portion116 of the annulus. (The anterior portion of the annulus should generally not be contracted because its tissue is part of the skeleton of the heart.) However, the portion of the sleeve deployed along the anterior portion of the annulus prevents dilation of the anterior annulus, because the sleeve is anchored at both ends of the anterior annulus, and, as mentioned above, the sleeve typically comprises a longitudinally non-extensible material. This deployment configuration may help prevent long-term resizing of the anterior annulus, which sometimes occurs after implantation of partial annuloplasty rings, such as C-bands.

For some applications, the non-contractible portion of sleeve26 (the portion without contracting member30) extends somewhat beyond one or both oftrigones142 or144 (in the posterior direction, away fromanterior portion116 of the annulus), such as up to 20 mm, such as up to 10 mm.

For some applications, at least oneanchor38 is coupled to cardiac tissue on the posterior side of rightfibrous trigone144, between the trigone and the end of contractingmember30. Similarly, at least oneanchor38 may be coupled to cardiac tissue on the posterior side of leftfibrous trigone142, between the trigone and the other end of contracting member30 (which, for some applications, is coupled tocontracting mechanism28, as shown inFIG. 5).

second coupling elements

256 and260 later in the implantation procedure.

Linkingmember250 has first and second linking member ends252 and254. Second linkingmember end254 comprises (e.g., is shaped so as to define, or is fixed to) afirst coupling element256. First linkingmember end252 is disposed longitudinally between second linkingmember end254 and a first sleeve end (eitherproximal end49, as shown, ordistal end51, not shown), exclusive. Second linkingmember end254 either protrudes from the second end of the sleeve, or is recessed within the second end of the sleeve (as shown, the second end of the sleeve is distal end51). A longitudinal portion of linkingmember250 in a vicinity of first linkingmember end252 is coupled to the sleeve. For example, the portion may be threaded through the fabric of the sleeve, and/or sewn (e.g., sutured) to the fabric of the sleeve to hold the linking member in place during deployment, and the linking member may be held in place after implantation by one or more ofanchors38, such as two ormore anchors38F. Optionally, the linking member is not initially coupled to the sleeve, but is instead held in place by a delivery tool during the implantation procedure, until being coupled to the sleeve by one or more of the anchors, for example. The coupled longitudinal portion may have a length of between 2 and 10 mm, and optionally includes first linking member end252 of the linking member.

Implantable structure

22 further comprises asecond coupling element260, which is configured to be coupleable tofirst coupling element256.Second coupling element260 typically is coupled toimplantable structure22 within 1.5 cm of the first end of sleeve26 (opposite the end mentioned above near which first linkingmember end252 is fixed), measured when the sleeve is fully longitudinally extended. As mentioned above, in the configuration shown inFIGS. 6 and 7A-B, this first end isproximal end49.

For some applications, such as shown inFIGS. 6 and 7A-B, contracting mechanism28 (e.g.,housing44 thereof) is disposed alongsleeve26 within 30 mm, such as within 15 mm, of the first sleeve end (i.e., the same end of the sleeve near which the second coupling element is coupled), measured whensleeve26 is fully longitudinally extended. For example, contracting mechanism28 (e.g.,housing44 thereof) may be fixed at the first sleeve end. Alternatively, for some applications, contracting mechanism28 (e.g.,housing44 thereof) is fixed at least 5 mm from the first sleeve end, e.g., between 5 and 30 mm, such as between 5 and 15 mm, from the first sleeve end.Second coupling element260 may be coupled to contracting mechanism28 (e.g., to housing44). Alternatively,second coupling element260 may be otherwise coupled to sleeve26 (such as directly coupled), in whichcase contracting mechanism28, e.g.,housing44 thereof, may be coupled tosleeve26 at a greater longitudinal distance from the end of the sleeve, and one or more ofanchors38 may be coupled to the sleeve longitudinally between the contracting mechanism and the sleeve end, such as described hereinabove with reference toFIGS. 1, 2A-I,3, and4.

Typically, linkingmember250 is substantially longitudinally non-extensible, i.e., its length is fixed. Typically, linkingmember250 comprises metal, such as Nitinol or stainless steel. For some applications, the linking member has a length of at least 2 cm, no more than 6 cm, and/or between 2 and 6 cm.

For some applications, the linking member is configured as a spring, which is typically curved, so as to be elastic in a radial direction, i.e., to be compressible like a bow or deflected beam. In these applications, the linking member is oriented such that it is pressed by elasticity against the anterior portion of the mitral annulus, i.e., the outer wall of the aorta, thereby holding the sleeve covering the linking member against the aortic wall.

For some applications, at least two of tissue anchors38 are coupled tosleeve26 at respective, different longitudinal sites alongside linkingmember250, within 6 cm of first linkingmember end252, such as within 2 to 6 cm of the first end. These tissue anchors may help set the proper direction of curvature of the linking member, for applications in which the linking member is curved.

Reference is made toFIGS. 8A-D, which are schematic illustrations of

coupling elements

256 and260, in accordance with respective applications of the present invention. For some applications, at least one of first and

second coupling elements

256 and260 comprises ahook270. Alternatively or additionally, for some applications, at least one of the first and second coupling elements comprises aloop272. In the configuration shown inFIG. 8A (andFIGS. 6 and 7A-B),first coupling element256 compriseshook270, andsecond coupling element260 comprises aloop272. In the configuration shown inFIG. 8B, both first and

second coupling elements

256 and260 comprisesrespective loops272, and the coupling elements are coupled together such as by placing one ofanchors38 through both loops and into cardiac tissue.

For some applications, first and

second coupling elements

256 and260 are configured to provide an adjustable-length connection between linkingmember250 and the first end of sleeve. Such an adjustable-length connection allows the effective length of linkingmember250 to be set during the implantation procedure in order to accommodate variations in individual patient anatomy. For some applications, such as shown inFIG. 8C,first coupling element256 comprises a flexibleelongate member274, which comprises a plurality ofprotrusions276 distributed along a portion of flexibleelongate member274. Flexibleelongate member274 is drawn through a loop defined bysecond coupling element260 until a desired length of linkingmember250 is achieved; one of the protrusions prevents loosening. Alternatively,second coupling element260 comprises flexible elongate member274 (having protrusions276), andfirst coupling element256 defines the loop through which flexibleelongate member274 is drawn (configuration not shown). For some applications, such as shown inFIG. 8D,first coupling element256 comprises a plurality ofloops272, arranged longitudinally (each loop is connected to an adjacent loop, either directly or such as by a short length of wire), andsecond coupling element260 comprises asingle loop272. The healthcare professional selects which ofloops272 offirst coupling element256 to couple with thesingle loop272 ofsecond coupling element260, in order to set the length of linkingmember250. Alternatively,second coupling element260 comprises the plurality ofloops272, andfirst coupling element256 comprises thesingle loop272, or both first and

second coupling elements

256 and260 comprise pluralities of loops (configurations not shown).

Reference is now made toFIGS. 9-17, which are schematic illustrations of additional configurations ofimplantable structure22, in accordance with respective applications of the present invention.FIGS. 9 and 12-16B show implantable structure22 (which typically comprises an annuloplasty ring) in a relaxed, non-contracted state.FIGS. 11A-D show several configurations of an elongated radial-force application element482, labeled with

reference numerals

482A,482B,482C, and482D, respectively. These configurations ofimplantable structure22 are generally similar to the configuration described hereinabove with reference toFIG. 1, except as follows, and may incorporate any of the features of the configuration described hereinabove with reference toFIG. 1, mutatis mutandis.

FIG. 10 showsimplantable structure22 implanted aroundmitral valve130, before a longitudinal portion ofsleeve26 has been contracted. For some applications, as shown inFIG. 10,implantable structure22 is implanted withcontracting mechanism28 disposed near leftfibrous trigone142, while for other applications (not shown, but similar to the arrangement shown inFIG. 7B),implantable structure22 is implanted withcontracting mechanism28 disposed near rightfibrous trigone144. This latter arrangement may facilitate placement of the first-deployed,distal-most anchor38 near rightfibrous trigone144, which is above the fossa ovalis, and the linking of first and

second coupling elements

456 and260 later in the implantation procedure, for applications in which these coupling elements are provided, such as described hereinbelow.

In these configurations,implantable structure22 further comprises elongated radial-force application element482, which is disposed entirely within a first longitudinal portion ofsleeve26. Elongated radial-force application element482 is configured to apply a force against a wall of the first longitudinal portion ofsleeve26 in at least one radially-outward direction. The applied force pushes the first longitudinal portion ofsleeve26 against tissue of the left atrium, such as against tissue of the annulus and/or the atrial wall, so as to inhibit blood flow betweensleeve26 and the tissue. It is generally desirable to inhibit blood flow betweensleeve26 and the annulus on anterior side, to avoid creating turbulence.

For some applications, elongated radial-force application element482 is configured to apply a force against the wall of at least 20 gram-force, no more than 1 kg-force, and/or between 20 gram-force and 1 kg-force, such as at least 50 gram-force, no more than 500 gram-force (e.g., no more than 300 gram-force), and/or between 50 gram-force and 500 gram-force (e.g., between 50 gram-force and 300 gram-force). For some applications, elongated radial-force application element482 is configured to apply the force generally constantly along the length of elongated radial-force application element482, e.g., with a variation of less than 20% along the length.

When implantingimplantable structure22, elongated radial-force application element482 is placed alonganterior portion116 of the annulus, betweenfibrous trigones142 and144 (a portion of elongated radial-force application element482 may extend beyond one or both of the trigones, such as for coupling toanchors38F, as described hereinbelow). If, upon initial placement, radial-force application element482 does not apply the force against the wall ofsleeve26 in the desired radial direction (e.g., in the direction of the atrial wall), the healthcare professional may rotate the radial-force application element482 within the sleeve, and/or rotate (e.g., twist) the first longitudinal portion ofsleeve26. Typically,longitudinal portion480 extends along at least 20 mm ofanterior portion116 of the annulus, and/or along at least 20%, no more than 100%, and/or between 20% and 100% ofanterior portion116 of the annulus, such as at least 30%, no more than 60%, and/or between 30% and 60% ofanterior portion116. Typically, in the configuration ofimplantable structure22 shown inFIGS. 9-10 and 12-16B, none ofanchors38 is coupled toanterior portion116 of the annulus.

Typically, elongated radial-force application element482 has a length of no more than 6 cm, measured whensleeve26 is fully longitudinally extended.

For some applications, elongated radial-force application element482 is rotationally asymmetric and not helically symmetric, such as shown inFIGS. 9-12 and 14-16B.

For some applications, such as shown inFIGS. 9-16B, elongated radial-force application element482 comprises aspringy element484. For some applications, at least a portion ofspringy element484 is curved at least partially about an inner surface of the wall ofsleeve26, such as shown inFIGS. 9, 10, 12, 14, 15, and 16A-B. Typically,springy element484 comprises an elastic material, such as a metal, such as Nitinol or stainless steel.

For some applications (such as when elongated radial-force application element482 comprises springy element484), as labeled inFIGS. 11A-D, elongated radial-force application element482 is shaped so as to define one or more axial base sections510 (e.g., exactly two

axial base sections

510A and510B, as shown inFIGS. 11A-D), and one or more offset sections512 (e.g., exactly one offsetsection512, as shown inFIG. 11A (andFIG. 10), or a plurality of offset sections512 (e.g., between two and 20, e.g., between two and ten, such as between two and six), as shown inFIGS. 11B-D). The one or more axial base sections510 are coaxial with alongitudinal axis514 of elongated radial-force application element482, and the one or more offsetsections512 are not coaxial withlongitudinal axis514. A greatest distance D between the one or more offsetsections512 andlongitudinal axis514 is typically at least 2 mm, no more than 10 mm (e.g., no more than 6 mm), and/or between 2 and 10 mm (e.g., between 2 and 6 mm), e.g., 4 mm.

For some applications, offset section(s)512 are at least partially straight, such as shown inFIGS. 11A and 11B. For some applications, offsetsections512 are at least partially curved, such as shown inFIGS. 11C and 11D. For some applications, offsetsections512 are at least partially serpentine, such as shown inFIG. 11D.

For some applications, the at least a portion ofspringy element484 is curved at least partially about the inner surface of the wall ofsleeve26 in a single circumferential direction, such as shown inFIGS. 9, 10, 14, 15, and 16A-B. Alternatively, for some applications, at least afirst portion485A ofspringy element484 is curved at least partially about the inner surface of the wall ofsleeve26 in a firstcircumferential direction486A, and at least asecond portion485B ofspringy element484 is curved at least partially about the inner surface of the wall ofsleeve26 in a secondcircumferential direction486B circumferentially opposite the first circumferential direction, such as shown inFIG. 12. This configuration may use any of the shapes shown inFIGS. 11A-D (with the shapes doubled), or other shapes. This configuration pushes against the wall ofsleeve26 and the tissue at at least two circumferential locations around the sleeve, and may help hold the rotational position of the sleeve, allow less accurate rotational alignment, and/or help compensate for anatomical variability.

For some applications, such as shown in Section A-A ofFIG. 9, elongated radial-force application element482 is configured to apply the force against the wall ofsleeve26 around an angle α (alpha) that is less than 100% of a perimeter of the wall ofsleeve26 around a centrallongitudinal axis516 ofsleeve26, such as around less than 75%, e.g., less than 50%, such as less than 25%, of the perimeter of the wall ofsleeve26. (Centrallongitudinal axis516 runs alongsleeve26; the cross-section shown in Section A-A ofFIG. 9 is perpendicular to the central longitudinal axis.) Force is not required to be applied around 100% of the perimeter of the wall ofsleeve26 because a circumferential portion of the wall faces the blood-filled volume of the chamber, rather than atrial tissue, and there would be no benefit to pushing the wall ofsleeve26 against the blood-filled volume.

For some applications, such as shown inFIG. 13, elongated radial-force application element482 is helically symmetric; for these applications,springy element484 typically comprises acoiled spring490. For some applications, when in a relaxed state, coiledspring490 has an outer diameter of at least 2.5 mm, no more than 10 mm, and/or between 2.5 and 10 mm, such as at least 3.5 mm, no more than 6 mm, and/or between 3.5 and 6 mm. For some applications, when in a relaxed state, the outer diameter of coiledspring490 is greater than (e.g., equals at least 110% of, such as at least 130% of, e.g. at least 150% of) an inner diameter of a secondlongitudinal portion492 that is entirely longitudinally distinct from firstlongitudinal portion480 ofsleeve26, when secondlongitudinal portion492 is fully radially expanded.Coiled spring490 is typically initially held constrained with a smaller diameter in a separate tube smaller than the inner diameter of the deployment sheath.

Reference is again made toFIGS. 9-16B. For some applications,longitudinal contracting member30 ofcontracting assembly40 is arranged only along at least a portion of secondlongitudinal portion492. For some of these applications, contractingassembly40 is configured to contract the at least a portion of the secondlongitudinal portion492.

Reference is made toFIG. 14. For some applications, first and second

longitudinal portions

480 and492 ofsleeve26 are configured such that firstlongitudinal portion480 either has, or is configured to assume, a first average internal diameter D1 that is greater than a second average internal diameter D2 of secondlongitudinal portion492. For example, first average internal diameter D1 may be at least 110% of D2, such as at least 150% of second average internal diameter D2. This larger average diameter enables elongated radial-force application element482 (e.g., springy element484) to push a large surface area ofsleeve26 against the atrial tissue, thereby better encouraging tissue growth, better inhibiting blood between the sleeve and the atrial tissue, and accommodating variations in individual patient anatomy. For some applications, first and second

longitudinal portions

480 and492 collectively extend along an entire length ofsleeve26. This configuration, as well as the various options described below, may be used in combination with any of the configurations described herein with reference toFIGS. 9-13 and/or 15.

For some applications, first average internal diameter D1 of firstlongitudinal portion480 ofsleeve26 is greater than second average internal diameter D2 of secondlongitudinal portion492 ofsleeve26, when both first and second

longitudinal portions

480 and492 are fully radially expanded (in these applications, typically both first and second

longitudinal portions

480 and492 are substantially radially non-extensible).

For some other applications, firstlongitudinal portion480 ofsleeve26 is radially elastic and thus able to stretch from an initial smaller average internal diameter to first average internal diameter D1, and secondlongitudinal portion492 ofsleeve26 is substantially radially non-extensible, and thus cannot expand to a diameter beyond second average internal diameter D2. For example, firstlongitudinal portion480 may comprise a first plurality of substantially non-extensible fibers that extend longitudinally along the first longitudinal portion, and a second plurality of elastic fibers that are arranged circumferentially around the first longitudinal portion (typically, woven with the first plurality of fibers). Typically, first and second

longitudinal portions

480 and492 ofsleeve26 are substantially longitudinally non-extensible, i.e., a length thereof is substantially constant, i.e., cannot be longitudinally stretched, under normal usage conditions. Optionally, first and second

longitudinal portions

480 and492 ofsleeve26 have a same diameter (equal to second average internal diameter D2) when firstlongitudinal portion480 is not elastically stretched. Alternatively, for some applications, first and second

longitudinal portions

480 and492 ofsleeve26 are woven, and firstlongitudinal portion480 ofsleeve26 is more loosely woven than secondlongitudinal portion492 ofsleeve26. Further alternatively, for some applications, firstlongitudinal portion480 ofsleeve26 is radially stretchable, and secondlongitudinal portion492 ofsleeve26 is substantially radially non-extensible. For example, firstlongitudinal portion480 may comprise a first plurality of substantially non-extensible fibers that extend longitudinally along the first longitudinal portion, and a second plurality of stretchable fibers that are arranged circumferentially around the first longitudinal portion (typically, woven with the first plurality of fibers).

For some applications, such as shown inFIGS. 9-10 and 12-15,sleeve26 has (a) a first sleeve end51 (which may correspond todistal end51 ofsleeve26, as shown, or to the proximal end, configuration not shown), and (b) a second sleeve end49 (which may correspond toproximal end49 ofsleeve26, as shown, or to the distal end, configuration not shown). For some applications, elongated radial-force application element482 has (a) a first radial-force-application-elementlongitudinal end496 that is between 2 and 6 cm fromfirst sleeve end51, measured whensleeve26 is fully longitudinally extended, and (b) a second radial-force-application-elementlongitudinal end498 that is within 1.5 cm offirst sleeve end51, measured whensleeve26 is fully longitudinally extended.

For some applications, such as shown inFIGS. 9-10 and 12-15, implantable structure22 (e.g., the annuloplasty ring) further comprises (a) afirst coupling element456, which is coupled to the annuloplasty ring within 1.5 cm offirst sleeve end51, measured whensleeve26 is fully longitudinally extended, and (b)second coupling element260, as described above with reference toFIGS. 6 and 7A-B.Second coupling element260 is configured to be coupleable tofirst coupling element456, and is fixed to implantable structure22 (e.g., the annuloplasty ring) within 1.5 cm ofsecond sleeve end49, measured whensleeve26 is fully longitudinally extended. For some applications, at least one of first and

second coupling elements

456 and260 comprises a hook. Alternatively or additionally, for some applications, at least one of the first and second coupling elements comprises a loop. For example, in the configurations shown inFIGS. 9-15,first coupling element456 comprises a hook, andsecond coupling element260 comprises a loop. Alternatively, for example, both the first and the second coupling elements comprises loops, such as shown inFIGS. 8B and 8D, and the coupling elements are coupled together such as by placing one ofanchors38 through both loops and into cardiac tissue.

Elongated radial-force application element482 is typically fixed tosleeve26 at least near first radial-force-application-elementlongitudinal end496, such that elongated radial-force application element482 is arranged as a cantilever. Typically, elongated radial-force application element482 is fixed tosleeve26 at least near first radial-force-application-elementlongitudinal end496, such that first radial-force-application-elementlongitudinal end496 is rotationally fixed with respect to the sleeve, in order to allow twisting of elongated radial-force application element482 to store spring energy in elongated radial-force application element482 near first radial-force-application-elementlongitudinal end496. The shape of first radial-force-application-elementlongitudinal end496 may aid in rotationally fixing the end with respect to the sleeve. For example, first radial-force-application-elementlongitudinal end496 may include a circumferentially-oriented component, as shown in the figures.

A portion of elongated radial-force application element482 may be threaded through the fabric of the sleeve, and/or sewn (e.g., sutured) to the fabric of the sleeve to hold the elongated radial-force application element in place during deployment, and/or the elongated radial-force application element may be held in place after implantation by one or more ofanchors38, such as two ormore anchors38F.

For some applications, such as shown inFIGS. 9-15, contracting mechanism28 (e.g.,housing44 thereof) is fixed alongsleeve26 within 30 mm, such as within 15 mm, of second sleeve end49 (i.e., the same end of the sleeve near whichsecond coupling element260 is coupled), measured whensleeve26 is fully longitudinally extended. For example, contracting mechanism28 (e.g.,housing44 thereof) may be fixed atsecond sleeve end49. Alternatively, for some applications, contracting mechanism28 (e.g.,housing44 thereof) is fixed at least 5 mm fromsecond sleeve end49, e.g., between 5 and 30 mm, such as between 5 and 15 mm, fromsecond sleeve end49.Second coupling element260 may be coupled to contracting mechanism28 (e.g., to housing44). Alternatively,second coupling element260 may be otherwise coupled to sleeve26 (such as directly coupled), in whichcase contracting mechanism28, e.g.,housing44 thereof, may be coupled tosleeve26 at a greater longitudinal distance from the end of the sleeve, and one or more ofanchors38 may be coupled to the sleeve longitudinally between the contracting mechanism and the sleeve end, such as described hereinabove with reference toFIGS. 1, 2A-I,3, and4.

For some applications, such as shown inFIGS. 9-14, implantable structure22 (e.g., the annuloplasty ring) further comprises a substantially longitudinallynon-extensible linking member450, i.e., a length thereof is substantially constant, i.e., cannot be longitudinally stretched, under normal usage conditions. Linkingmember450 typically helps prevent long-term dilation of the anterior annulus. Linkingmember450 is typically configured not to apply any force to the wall of firstlongitudinal portion480 ofsleeve26. Typically, linkingmember450 is not configured as a spring. For some applications, linkingmember450 comprises a metal (e.g., Nitinol or stainless steel) or a polymer. For some applications, linkingmember450 is rigid, while for other applications, the linking member is not rigid.

Linkingmember450 has first and second linking-member ends452 and454. Linkingmember450 is at least partially disposed within and covered by firstlongitudinal portion480 ofsleeve26. Typically, at least 30%, such as at least 75% or at least 90% of a length of linkingmember450 is disposed within and covered by firstlongitudinal portion480 ofsleeve26. Over time after implantation, linkingmember450 becomes fixed toanterior portion116 of the annulus. Second linking-member end454 comprises (e.g., is shaped so as to define, or is fixed to)first coupling element456. Second linking-member end454 either protrudes fromfirst sleeve end51, or is recessed withinfirst sleeve end51. A longitudinal portion of linkingmember450 in a vicinity of first linking-member end452 is typically coupled tosleeve26. For example, the portion may be threaded through the fabric of the sleeve, and/or sewn (e.g., sutured) to the fabric of the sleeve to hold the linking member in place during deployment. Optionally, a longitudinal portion of linkingmember450 in a vicinity of first linking-member end452 is held in place after implantation by one or more ofanchors38, such as two ormore anchors38F (configuration not shown). Optionally, the linking member is not initially coupled to the sleeve, but is instead held in place by a delivery tool during the implantation procedure, until being coupled to the sleeve during the implantation procedure. Typically, linkingmember250 has a length of at least 2 cm, no more than 6 cm, and/or between 2 and 6 cm.

For some applications, at least firstlongitudinal portion480 ofsleeve26 is substantially longitudinally non-extensible, i.e., a length thereof is substantially constant, i.e., cannot be longitudinally stretched, under normal usage conditions. In these applications, firstlongitudinal portion480 typically helps prevent long-term dilation of the anterior annulus.

For some applications, such as shown inFIG. 15,first coupling element456 is fixed to the wall ofsleeve26 within 1.5 cm offirst sleeve end51, measured whensleeve26 is fully longitudinally extended.Implantable structure22 typically does not comprise linkingmember450 in these applications. In these applications, at least firstlongitudinal portion480 ofsleeve26 is substantially longitudinally non-extensible, and firstlongitudinal portion480 typically helps prevent long-term dilation of the anterior annulus.

Reference is made toFIGS. 9-15. Typically,sleeve26 is placed entirely around an annulus of the atrioventricular valve, e.g., the mitral valve. For applications in whichsleeve26 has first and second sleeve ends51 and49, as described hereinabove with reference toFIGS. 9-14,sleeve26 is introduced into the left atrium while first and second sleeve ends51 and49 are not coupled to each other, and thereafter, in the left atrium,sleeve26 is arranged entirely around the annulus to form the closed loop.

Reference is still made toFIGS. 9-16. For some applications, during placement, after fasteningsleeve26 to the portion of the annulus, the healthcare professional twists elongated radial-force application element482 (and optionally firstlongitudinal portion480 of sleeve26), and then, typically, links first and

second coupling elements

456 and260. Optionally, such twisting may serve one or both of the following purposes: (1) the twisting may store energy inspringy element484 for exertion of torque against the wall of the sleeve, and (2) the twisting may rotationally alignspringy element484 in the desired radial direction. Alternatively or additionally to twisting for the first of these purposes,springy element484 may be pre-loaded (twisted) to store energy before implantation in the subject, such as immediately before implantation or during manufacture.

Reference is again made toFIGS. 8A-D. The techniques described with reference to these figures regardingcoupling element256 may be implemented forcoupling element456 of the configuration described with reference toFIGS. 9-15.

Reference is made toFIGS. 16A-B, which are schematic illustrations ofimplantable structure22 in whichsleeve26 is shaped so as to define an integrally closed loop having no sleeve ends, in accordance with respective applications of the present invention. In these applications, the wall ofsleeve26 typically is shaped so as to define alateral opening500 through which anchordeployment manipulator24 is introduced. For some applications, elongated radial-force application element482 has (a) a first radial-force-application-elementlongitudinal end496 that is at least 2 cm, no more than 6 cm, and/or between 2 and 6 cm fromhousing44 of contracting assembly40 (housing44 is fixed to sleeve26), measured whensleeve26 is fully longitudinally extended, and (b) a second radial-force-application-elementlongitudinal end498 that is within 1.5 cm ofhousing44, measured whensleeve26 is fully longitudinally extended. Alternatively, for some applications, first radial-force-application-elementlongitudinal end496 is within 1.5 cm ofhousing44, measured whensleeve26 is fully longitudinally extended, and second radial-force-application-elementlongitudinal end498 is at least 2 cm, no more than 6 cm, and/or between 2 and 6 cm fromhousing44 ofcontracting assembly40, measured whensleeve26 is fully longitudinally extended.

For some applications, such as shown inFIG. 16B, first and second

longitudinal portions

480 and492 ofsleeve26 are configured such that firstlongitudinal portion480 either has, or is configured to assume, a first average internal diameter D1 that is greater than a second average internal diameter D2 of secondlongitudinal portion492. For example, first average internal diameter D1 may be at least 110% of second average internal diameter D2, such as at least 150% of second average internal diameter D2. First average internal diameter D1 may be achieved using the techniques described hereinabove with reference toFIG. 14. For other applications, such as shown inFIG. 16A, the entire sleeve (i.e., first and secondlongitudinal portions480 and492) has a constant internal diameter.

For some applications, as shown inFIGS. 16A-B,implantable structure22 is implanted withcontracting mechanism28 disposed near leftfibrous trigone142, while for other applications (not shown, but similar to the arrangement shown inFIG. 7B),implantable structure22 is implanted withcontracting mechanism28 disposed near rightfibrous trigone144.

Reference is now made toFIG. 17, which is a schematic illustration of another configuration ofimplantable structure22 implanted around the mitral valve, in accordance with an application of the present invention. In this configuration, elongated radial-force application element482 comprises aninflatable element494, such as a balloon. After fasteningsleeve26 to the portion of the annulus (and, optionally, after linking first andsecond coupling elements456 and260), the healthcare professional inflatesinflatable element494, typically with a liquid (such as saline solution) or a gel. For some applications,inflatable element494 is provided separately fromimplantable structure22, and the healthcare professional introducesinflatable element494, while uninflated, intosleeve26, typically after fasteningsleeve26 to the portion of the annulus (and, optionally, after linking first andsecond coupling elements456 and260), and then inflatesinflatable element494. These inflation techniques may be used with any of the techniques described herein with reference toFIGS. 9-16B, mutatis mutandis.

For some applications, as shown inFIG. 17,implantable structure22 is implanted withcontracting mechanism28 disposed near leftfibrous trigone142, while for other applications (not shown, but similar to the arrangement shown inFIG. 7B),implantable structure22 is implanted withcontracting mechanism28 disposed near rightfibrous trigone144. This latter arrangement may facilitate placement of the first-deployed,distal-most anchor38 near rightfibrous trigone144, which is above the fossa ovalis, and the linking of first and

second coupling elements

Reference is now made toFIGS. 18A and 18B.FIG. 18A is a schematic illustration of another configuration ofimplantable structure22, prior to implantation, in accordance with an application of the present invention, andFIG. 18B is a schematic illustration ofimplantable structure22 in the configuration ofFIG. 18A after implantation entirely around the annulus ofmitral valve130, before a longitudinal portion ofsleeve26 has been contracted, in accordance with an application of the present invention. In this configuration,flexible sleeve26 is placed entirely around an annulus ofmitral valve130 in a closed loop. For some applications,sleeve26 is introduced intoleft atrium124 while first and second sleeve ends are not coupled to each other. Thereafter, in the left atrium, the sleeve is arranged entirely around the annulus to form the closed loop.

Sleeve

26 is fastened to the annulus by coupling a plurality of tissue anchors38 to the annulus. Tissue anchors38 are coupled with:

- a first non-zero longitudinal density along a posterior portion of the annulus between left and rightfibrous trigones142 and144 of the annulus, including the trigones, which density is equal to (a) a number of tissue anchors38 coupled to the annulus along the posterior portion of the annulus divided by (b) a length of the posterior portion of the annulus (measured along the annulus),
- and a second non-zero longitudinal density along an anterior portion of the annulus between left and rightfibrous trigones142 and144 of the annulus, not including the trigones, which density is equal to (a) a number of tissue anchors38 coupled to the annulus along the anterior portion of the annulus divided by (b) a length of the anterior portion of the annulus (measured along the annulus).

The first longitudinal density is greater than the second longitudinal density. For some applications, the first longitudinal density is at least twice the second longitudinal density, such as at least 2.5 the second longitudinal density, e.g., at least 3 times the second longitudinal density. For example, tissue anchors38A (and, optionally38C) may be fastened along the posterior portion of the annulus, and tissue anchors38B may be fastened along the anterior portion of the annulus. After the tissue anchors are fastened to the annulus, a longitudinal portion of the sleeve is contracted, such as by causing the longitudinal contracting member to apply a force to the longitudinal portion of the sleeve, such as by actuatingcontracting assembly40.

Alternatively or additionally, for some applications,sleeve26 comprises a plurality ofradiopaque markers39, which are positioned along the sleeve at respective longitudinal sites, such as described hereinabove with reference toFIG. 1. The markers may provide an indication in a radiographic image (such as a fluoroscopy image) of how much of the sleeve has been deployed at any given point during an implantation procedure, in order to enable setting a desired distance betweenanchors38 along the sleeve, and thus the desired differing longitudinal densities of the anchors.

For some applications, as shown inFIG. 18B,implantable structure22 is implanted withcontracting mechanism28 disposed near leftfibrous trigone142, while for other applications (not shown, but similar to the arrangement shown inFIG. 7B),implantable structure22 is implanted withcontracting mechanism28 disposed near rightfibrous trigone144.

Reference is now made toFIG. 19, which is a schematic illustration ofimplantable structure22 after implantation around the annulus ofmitral valve130, in accordance with an application of the present invention. In this configuration,flexible sleeve26 is placed at least partially around an annulus ofmitral valve130, such as partially around the annulus, as shown inFIG. 19, or entirely around the annulus in a closed loop, such as shown inFIG. 4, 5, 7A-B,10,16A-B,17, or18B, optionally using any of the techniques described herein with reference to these figures. For some applications in which the sleeve is placed entirely around the annulus,sleeve26 is introduced intoleft atrium124 while first and second sleeve ends are not coupled to each other; thereafter, in the left atrium,sleeve26 is arranged entirely around the annulus to form the closed loop.FIG. 19 shows the annulus before a longitudinal portion ofsleeve26 has been contracted, as described below.

Sleeve

26 is fastened to the annulus by coupling a plurality of tissue anchors38 to the annulus, including first, second, and third tissue anchors38G,38H, and38I, as follows:

- one or more first tissue anchors38G are coupled to the annulus along a lateral scallop (P1) of the posterior leaflet, with a first longitudinal density, which density is equal to (a) a number of first tissue anchors38G coupled to the annulus along the lateral scallop (P1) divided by (b) a length of the lateral scallop (P1) along the annulus,
- a plurality of second tissue anchors38H (e.g., at least 3 tissue anchors, such as at least five tissue anchors) are coupled to the annulus along a middle scallop (P2) of the posterior leaflet, with a second longitudinal density, which density is equal to (a) a number of second tissue anchors38H coupled to the annulus along the middle scallop (P2) divided by (b) a length of the middle scallop (P2) along the annulus, and
- one or more third tissue anchors38I are coupled to the annulus along a medial scallop (P3) of the posterior leaflet, with a third longitudinal density, which density is equal to (a) a number of third tissue anchors38I coupled to the annulus along the medial scallop (P3) divided by (b) a length of the medial scallop (P3) along the annulus.

Tissue anchors38 may optionally comprise additional tissue anchors other than tissue anchors38G,38H, and38I, not coupled along the posterior leaflet. After the tissue anchors are fastened to the annulus, a longitudinal portion ofsleeve26 is contracted, such as by causing the longitudinal contracting member to apply a force to the longitudinal portion of the sleeve, such as by actuatingcontracting assembly40.

For some applications, as shown inFIG. 19,implantable structure22 is implanted withcontracting mechanism28 disposed near leftfibrous trigone142, while for other applications (not shown, but similar to the arrangement shown inFIG. 7B),implantable structure22 is implanted withcontracting mechanism28 disposed near rightfibrous trigone144.

Reference is now made toFIG. 20, which is a schematic illustration ofimplantable structure22 after implantation around the annulus ofmitral valve130, in accordance with an application of the present invention.FIG. 20 showsimplantable structure22 after a longitudinal portion ofsleeve26 has been contracted, such as by actuatingcontracting assembly40. The techniques described with reference toFIG. 20 may optionally be used in combination with the techniques described above with reference toFIG. 19.

Tissue anchors38, including second tissue anchors38H, comprise respective anchor heads320 andtissue coupling elements322. Typically, anchor heads320 are circular; alternatively, they have another shape, such as of an ellipse or a polygon (e.g., a hexagon or a square). The plurality of tissue anchors38 are coupled to the annulus such that, after the longitudinal portion ofsleeve26 has been contracted (such as by actuatingcontracting assembly40 to contract the longitudinal portion), each of anchor heads320 of at least two of second tissue anchors38H coupled along the middle scallop (P2) touches at least one longitudinally-adjacent anchor head320; for example, each of anchor heads320 of at least three of tissue anchors38H touches at least one longitudinally-adjacent anchor head320.

Typically, before the longitudinal portion ofsleeve26 has been contracted, anchor heads320 of the at least two of second tissue anchors38H do not touch any longitudinally-adjacent anchor heads320. Before the longitudinal portion ofsleeve26 has been contracted, the anchors are coupled to the sleeve and tissue at distances between the anchors that are less than the planned distances that the anchors move toward each other during contraction of the longitudinal portion ofsleeve26. As a result, the anchor heads touch each other upon such contraction.

By way of example,FIG. 20 shows three oftissue anchors38H touching at least one longitudinally-adjacent anchor head320. Each of the longitudinally-outer touching anchor heads touches one longitudinally-adjacent anchor head (the middle longitudinally-touching anchor head), and the middle longitudinally-touching anchor head touches two longitudinally-adjacent anchor heads (the outer touching anchor heads).

This touching of longitudinally-adjacent anchor heads320 inhibits longitudinal contraction ofsleeve26 in the longitudinal area of these anchors, so as to facilitate reshaping of the annulus in a desired manner. These longitudinally-adjacent anchor heads320 thus are dual-function, and serve to both anchor their respective anchors to the sleeve and to inhibit contraction of the sleeve.

For some applications, as shown inFIG. 20, the plurality of tissue anchors38 is coupled to the annulus such that, after the longitudinal portion ofsleeve26 has been contracted, such as by causing the longitudinal contracting member to apply a force to the longitudinal portion of the sleeve, such as by actuating contracting assembly40:

- none of anchor heads320 of first tissue anchors38G coupled along the lateral scallop (P1) touches any of the other anchor heads of tissue anchors38; and/or
- none of anchor heads320 of third tissue anchors38I coupled along the medial scallop (P3) touches any of the other anchor heads of tissue anchors38.

For some applications, the plurality of tissue anchors38 are coupled to the annulus such that, after the longitudinal portion ofsleeve26 has been contracted, such as by causing the longitudinal contracting member to apply a force to the longitudinal portion of the sleeve, such as by actuating contracting assembly40:

- a first number of anchor heads320 of first tissue anchors38G coupled along the lateral scallop (P1) touch at least one longitudinally-adjacent anchor head, and (b) a second number of anchor heads320 of the tissue anchors coupled along the middle scallop (P2) touch at least one longitudinally-adjacent anchor head, the second number greater than the first number; and/or
- a second number of anchor heads320 of second tissue anchors38H coupled along the middle scallop (P2) touch at least one longitudinally-adjacent anchor head, and (b) a third number of anchor heads320 of third tissue anchors38I coupled along the medial scallop (P3) touch at least one longitudinally-adjacent anchor head, the second number greater than the third number.

For some applications, as shown inFIG. 20,implantable structure22 is implanted withcontracting mechanism28 disposed near leftfibrous trigone142, while for other applications (not shown, but similar to the arrangement shown inFIG. 7B),implantable structure22 is implanted withcontracting mechanism28 disposed near rightfibrous trigone144.

Reference is now made toFIG. 21, which is a schematic illustration ofimplantable structure22 after implantation around the annulus ofmitral valve130, in accordance with an application of the present invention.FIG. 21 shows the annulus before a longitudinal portion ofsleeve26 has been contracted, as described below. The techniques described with reference toFIG. 21 may optionally be used in combination with the techniques described hereinabove with reference toFIG. 19, and/or the techniques described hereinabove with reference toFIG. 20.

In this configuration,flexible sleeve26 is placed at least partially around an annulus ofmitral valve130, such as partially around the annulus, as shown inFIG. 21, or entirely around the annulus in a closed loop, such as shown inFIGS. 4, 5, 7A-B,10,16A-B,17, or18B, optionally using any of the techniques described with reference to these figures. For some applications in which the sleeve is placed entirely around the annulus,sleeve26 is introduced intoleft atrium124 while first and second sleeve ends are not coupled to each other; thereafter, in the left atrium,sleeve26 is arranged entirely around the annulus to form the closed loop.

Sleeve

26 is fastened to the annulus by coupling a plurality of tissue anchors38 to the annulus, including tissue anchors38J and38K, such that:

- afirst set324 of exactly three of tissue anchors38J is disposed in succession along a first portion oflongitudinal contracting member30 with a first distance D9 between longitudinal-end tissue anchors offirst set324, measured along the annulus, and
- asecond set328 of exactly three of tissue anchors38K is disposed in succession along a second portion oflongitudinal contracting member30 with a second distance D10 between longitudinal-end tissue anchors ofsecond set328, measured along the annulus,

First distance D9 equals at least twice second distance D10, such as at least 2.5 times second distance D10, e.g., at least 3 times second distance D10. First distance D9 is measured between closest portions of the longitudinal-end tissue anchors offirst set324, and second distance D10 is measured between closest portions of the longitudinal-end tissue anchors ofsecond set328. First and

second sets

324 and328 do not share any common tissue anchors38. Typically, the plurality of tissue anchors38 comprises additional tissue anchors other than tissue anchors38J and38K. After the tissue anchors are fastened to the annulus, a longitudinal portion ofsleeve26 is contracted by causing the longitudinal contracting member to apply a force to the longitudinal portion of the sleeve, such as by actuatingcontracting assembly40. Providing the greater number of anchoring points withsecond set328 better distributes forces among the anchors of this set.

For some applications, as shown inFIG. 21,implantable structure22 is implanted withcontracting mechanism28 disposed near leftfibrous trigone142, while for other applications (not shown, but similar to the arrangement shown inFIG. 7B),implantable structure22 is implanted withcontracting mechanism28 disposed near rightfibrous trigone144.

Reference is now made toFIGS. 22A-D, which are schematic illustrations of another configuration ofsystem20 for repairing a dilated atrioventricular valve, and a method for deploying the system, in accordance with an application of the present invention. This configuration may be used in combination with any of the techniques and configurations described herein with reference toFIGS. 1, 2A-I,3,19,20,21,24,25A-B, and/or26.

In this configuration,system20 further comprises a linkingbridge element200, which is configured to be coupled tosleeve26 in order to link first and second sleeve ends51 and49 ofsleeve26 ofimplantable structure22 via linkingbridge element200. To this end, linkingbridge element200 typically comprises first and second

bridge coupling interfaces

210A and210B, which are configured to be coupled to corresponding first and second

sleeve coupling interfaces

212A and212B ofsleeve26, which are disposed within 1.5 cm of first and second sleeve ends51 and49, respectively, measured when the sleeve is fully longitudinally extended, such as at first and second sleeve ends51 and49, respectively. For example, first and second

bridge coupling interfaces

210A and210B may comprise female interfaces (as shown), and first and second

sleeve coupling interfaces

212A and212B may comprise male interfaces (as shown), which are configured to snap into the female interfaces. Alternatively, first and second

sleeve coupling interfaces

212A and212B may comprise female interfaces, such as rings (e.g., comprising a metal or a plastic) integrated into the wall of sleeve26 (configurations not shown), and first and second

bridge coupling interfaces

210A and210B may comprise male interfaces (configuration not shown), which are configured to snap into the female interfaces. Further alternatively, the interfaces comprise other coupling structures, as is known in the art, such as coupling structures that snap together.

Typically, linkingbridge element200 has a length of at least 1 cm, no more than 5 cm, and/or between 1 and 5 cm, such as at least 1.5 cm, no more than 3.5 cm, and/or between 1.5 and 3.5 cm, e.g., 2 cm. Typically, first and second

bridge coupling interfaces

210A and210B are disposed within 1 cm (such as within 0.5 cm) of first and second ends216A and216B of linkingbridge element200, respectively, e.g., between 0.5 cm and 1 cm of first and second ends216A and216B of linkingbridge element200, respectively. For some applications, linkingbridge element200 comprises a metal or a polymer that provides longitudinal stability while maintaining some flexibility in other directions. Optionally, linkingbridge element200 further comprises a fabric or other coating for tissue growth enhancement. For some applications, linkingbridge element200 comprises elongated radial-force application element482, such as described hereinabove with reference toFIGS. 9-15 and/or 17.

For some applications,system20 comprises first and second flexible

longitudinal guide members

214A and214B, which are removably coupled tosleeve26 within 1.5 cm of first and second sleeve ends51 and49 (e.g., with 0.5 cm of the sleeve ends, or at the sleeve ends), respectively, measured when the sleeve is fully longitudinally extended. First and second flexible

longitudinal guide members

214A and214B extend from first and second sleeve ends51 and49, respectively, away fromsleeve26. First and second flexible

longitudinal guide members

214A and214B may be directly or indirectly coupled tosleeve26. For configurations in which first and second flexible

longitudinal guide members

214A and214B are indirectly coupled tosleeve26, the longitudinal guide members may be coupled to respective intermediary elements at locations beyond the end of the sleeve (but still within 1.5 cm of the respective sleeve ends). For example, first and second flexible

longitudinal guide members

214A and214B may be (a) removably coupled to first and second

sleeve coupling interfaces

212A and212B, respectively (in which case the longitudinal guide members may be indirectly coupled to the sleeve), and/or (b) the wall of sleeve26 (in which case the longitudinal guide members are directly coupled to the sleeve). For example, first and second flexible

longitudinal guide members

214A and214B may comprise respective sutures, wires, or strings.

The longitudinal guide members are configured to guide first and second

bridge coupling interfaces

210A and210B to corresponding locations onsleeve26, such as first and second

sleeve coupling interfaces

212A and212B, during an implantation procedure, as shown inFIGS. 22A-C. The longitudinal guide members removably pass through respective openings defined by linkingbridge element200, and then through adelivery tube220 in which linkingbridge element200 is disposed for delivery to the atrium. For some applications, the respective openings are defined by first and second

bridge coupling interfaces

210A and210B, respectively (as shown). For other applications, the respective openings are located elsewhere on linkingbridge element200, typically within 10 mm, such as within 5 mm, of first and second

bridge coupling interfaces

210A and210B, respectively. (Optionally,longitudinal member86, described hereinabove with reference toFIG. 2I, also passes throughdelivery tube220.)

For some applications, each of the longitudinal guide members is doubled over and threaded through its respective sleeve coupling interface and/or sleeve end. After the linking bridge element has been coupled tosleeve26 ofimplantable structure22, the longitudinal guide members are removed by pulling on one end of each of the longitudinal guide members, typically from outside of the patient's body. Alternatively, each of the longitudinal guide members is decoupled from the sleeve in some other manner, such as using techniques described in the above-mentioned '604 application for decouplinglongitudinal member86 fromcontracting mechanism40.

Typically, as described hereinabove,implantable structure22 compriseslongitudinal contracting member30, which is configured to longitudinally contract a longitudinal portion ofsleeve26, as described hereinabove.Longitudinal contracting member30 may be disposed with respect to the sleeve in any of the arrangements described hereinabove, including those regarding the extent to which the contracting member extends along the length of sleeve. First and second flexible

longitudinal guide members

214A and214B are separate and distinct fromlongitudinal contracting member30; in other words, first and second flexible

longitudinal guide members

214A and214B are not fixed tolongitudinal contracting member30, and are not parts of a common longitudinal member.

Typically, when first and second flexible

longitudinal guide members

214A and214B are removably coupled tosleeve26 of implantable structure22:

- no portion of either first flexiblelongitudinal guide member214A or second flexiblelongitudinal guide member214B is disposed more than 1.5 cm from first and second sleeve ends51 and49, respectively, measured when the sleeve is fully longitudinally extended;
- first and second flexiblelongitudinal guide members214A and214B are collectively disposed along less than 30% of a length ofsleeve26, such as less than 5% of the length of the sleeve, measured when the sleeve is fully longitudinally extended; and/or
- for applications in whichimplantable structure22 compriseslongitudinal contracting member30, first and second flexiblelongitudinal guide members214A and214B do not longitudinally overlap longitudinal contracting member30 (i.e., are not disposed at any common longitudinal locations with longitudinal contracting member30).

Alternatively, for some applications,system20 comprises a single flexible longitudinal guide member214 which removably passes through the entire sleeve26 (configuration not shown). After the linking bridge element has been coupled tosleeve26 ofimplantable structure22, the longitudinal guide member is removed by pulling on one end of the longitudinal guide member, typically from outside of the patient's body. Alternatively, the longitudinal guide member is decoupled from the sleeve in some other manner, such as using techniques described in the above-mentioned '604 application for decouplinglongitudinal member86 fromcontracting mechanism40.

After first and second

bridge coupling interfaces

210A and210B have been guided over first and second flexible

longitudinal guide members

214A and214B to corresponding first and second

sleeve coupling interfaces

212A and212B, as shown in FIGS.22A-C, first and second

bridge coupling interfaces

210A and210B are coupled to corresponding first and second

sleeve coupling interfaces

212A and212B, also as shown inFIG. 24C. For example, first and

second tubes

222A and222B may be introduced throughdelivery tube220 and over first and second flexible

longitudinal guide members

214A and214B, respectively, and used to push the corresponding coupling interfaces against each other, until they snap together, as shown inFIG. 22C.

FIG. 22D shows linkingbridge element200 coupled tosleeve26 ofimplantable structure22, after the delivery tool has been removed from the atrium.

For applications in whichimplantable structure22 compriseslongitudinal contracting member30, the implantation method typically comprises:

- during a percutaneous transcatheter procedure, placingsleeve26 ofimplantable structure22 partially around an annulus of a valve of a subject, such as a mitral valve or tricuspid valve (typically around all or a portion of a posterior portion of the annulus between fibrous trigones of the valve);
- anchoringsleeve26 to cardiac tissue, such as described hereinabove with reference toFIGS. 2G-I;
- coupling linkingbridge element200 tosleeve26, as described hereinabove, typically along all or a portion of an anterior portion of the annulus between the fibrous trigones; and
- thereafter, contracting a longitudinal portion ofsleeve26 by causinglongitudinal contracting member30 to apply a contracting force to the longitudinal portion of the sleeve, as described hereinabove.

Thus, the contracting of the sleeve is not performed simultaneously with the coupling of the linking bridge element to the sleeve. Moreover,longitudinal contracting member30 does not serve as either of first and second flexible

longitudinal guide members

214A and214B.

Optionally, for some applications,system20 comprises one or more bridge anchors224 (e.g., one, two, or three bridge anchors224), which are used to couple linkingbridge element200 to tissue at the anterior portion of the annulus. For some applications, the one or more bridge anchors224 are deployed usinganchor deployment manipulator24, described hereinabove.

Reference is now made toFIGS. 23A-B, which are schematic illustrations of another configuration of linkingbridge element200, in accordance with an application of the present invention. Other than as described below, this configuration is identical to the configuration described hereinabove with reference toFIGS. 22A-D.

In this configuration, first and second

bridge coupling interfaces

210A and210B are male interfaces, which are configured to pierce the wall ofsleeve26, thereby becoming coupled to the sleeve. For example, the coupling elements may be shaped as harpoons or other barbed structures. In this configuration,sleeve26 typically does not comprise any coupling interfaces or coupling elements.

Reference is now made toFIG. 24, which is a schematic illustration ofcontracting mechanism28, disassembled to show a relationship among individual components of the contracting mechanism, in accordance with an application of the present invention. The components are arranged and function as described with reference toFIG. 7 of the above-mentioned '604 publication, mutatis mutandis.

Reference is made toFIGS. 25A-B and26, which are schematic illustrations of avalve prosthesis assembly400, in accordance with respective applications of the present invention.Valve prosthesis assembly400 comprises aprosthetic heart valve410 that is couplable to a base ring422.Prosthetic heart valve410 is used to replace a native diseased heart valve.Valve410 comprises a plurality ofartificial leaflets430, which comprise a pliant material.Valve410 may implement techniques known in the artificial valve art, such as described, for example, in US Patent Application Publication 2007/0255400 to Parravicini et al., US Patent Application Publication 2004/0122514 to Fogarty et al., US Patent Application Publication 2007/0162111 to Fukamachi et al., and/or US Patent Application Publication 2008/0004697 to Lichtenstein et al., all of which are incorporated herein by reference.

Valve

410 further comprises anannular base432, to whichartificial leaflets430 are coupled.Annular base432 is configured to be couplable to base ring422 during an implantation procedure. For example, as shown inFIG. 26, base ring422 may comprise one ormore coupling elements434, such as clips or magnets, which are configured to be coupled to corresponding coupling elements on a lower surface of annular base432 (not visible in the figures). Alternatively or additionally,annular base432 may be configured to be placed within the opening defined by base ring422, as shown inFIG. 25A. To hold the annular base coupled to the base ring, the base ring is tightened around the annular base, as shown inFIG. 25B, typically using one or more of the techniques described hereinabove for contracting implantable structures. Typically,valve prosthesis assembly400, such asannular base432 thereof, is configured to push and hold open the intact diseased native leaflets.

Base ring422 implements one or more of the techniques ofimplantable structure22 described hereinabove. In particular, base ring422 may be coupled to the annulus of the native diseased valve using the anchoring techniques described hereinabove. In addition, base ring422 typically comprisessleeve26 andcontracting mechanism28, which may, for some applications, comprise a rotatable structure, such as aspool46, which is typically implemented using techniques described herein. The contracting mechanism is arranged to contract base ring422, e.g., the rotatable structure is arranged such that rotation thereof contracts base ring422, typically using techniques described herein. Such tightening may serve to couple base ring422 toannular base432, as shown inFIG. 25B. Alternatively or additionally, such tightening sets the desired dimensions of the base ring, in order to align the coupling elements of the base ring with those ofvalve410, thereby enabling tight coupling, such as for the applications described with reference toFIG. 26.

For some applications, as shown inFIG. 26, base ring422 comprises a partial ring, such as described hereinabove with reference toFIGS. 2A-I,19,20, and21. For other applications, as shown inFIGS. 25A-B, the base ring is arranged as a full ring, such as described hereinabove with reference toFIGS. 4, 5, 7A-B,10,16A-B,17, and18B.

Valve prosthesis assembly

400 is typically implanted in a minimally invasive transcatheter or percutaneous procedure. The procedure begins with the introduction and implantation of base ring422 into the heart, such as using techniques for implantingimplantable structure22, described hereinabove with reference toFIGS. 2A-I.Prosthetic heart valve410 is subsequently introduced into the heart and coupled to base ring422, as described above.Valve prosthesis assembly400 is typically used for replacement of a diseased native mitral valve, aortic valve, tricuspid valve, or pulmonary valve.

For some applications,system20 further comprises a closure mechanism, such as described in above-mentioned US Patent Application Publication 2012/0330411, with reference toFIGS. 16-17B thereof.

For some applications,system20 further comprises a flexible pusher element, such as described and shown in US Patent Application Publication 2010/0286767, which is incorporated herein by reference, with reference toFIG. 8 thereof. The pusher element aids with accurately positioningsuccessive anchors38 during an implantation procedure, such as described hereinabove with reference toFIGS. 2H and 21. For some applications,system20 further comprises a pusher tube that is applied toproximal end49 ofsleeve26, such as described in the above-mentioned '604 *publication, with reference toFIGS. 14 and/or 18A-B thereof. For some applications,system20 further comprises a steerable tube, such as described in the above-mentioned '604 publication, with referenced toFIG. 15 thereof, or with reference toFIG. 16 thereof. For some applications,system20 further comprises a pulling wire, such as described in the above-mentioned '604 publication, with referenced toFIG. 17 thereof. For some applications,system20 further comprises an external control handle, such as described in the above-mentioned '604 publication, with referenced toFIG. 19 thereof. For some applications, contractingassembly40 andimplantable structure22 are configured as described with reference toFIG. 23 of the above-mentioned '604 publication, mutatis mutandis.

For some applications of the present invention,system20 is used to treat an atrioventricular valve other than the mitral valve, i.e., the tricuspid valve. For these applications,implantable structure22 and other components ofsystem20 described hereinabove as being placed in the left atrium are instead placed in the right atrium. Althoughimplantable structure22 is described hereinabove as being placed in an atrium, for some application the implantable structure is instead placed in either the left or right ventricle.

The scope of the present invention includes applications described in the following applications, which are incorporated herein by reference. In an application, techniques and apparatus described in one or more of the following applications are combined with techniques and apparatus described herein:

- PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral Valve treatment techniques,” filed Mar. 15, 2006;
- U.S. Provisional Patent Application 60/873,075 to Gross et al., entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;
- U.S. Provisional Patent Application 60/902,146 to Gross et al., entitled, “Mitral valve closure techniques,” filed on Feb. 16, 2007;
- U.S. Provisional Patent Application 61/001,013 to Gross et al., entitled, “Segmented ring placement,” filed Oct. 29, 2007;
- PCT Patent Application PCT/IL07/001503 to Gross et al., entitled, “Segmented ring placement,” filed on Dec. 5, 2007, which published as PCT Publication WO 08/068756;
- U.S. patent application Ser. No. 11/950,930 to Gross et al., entitled, “Segmented ring placement,” filed on Dec. 5, 2007, which published as US Patent Application Publication 2008/0262609;
- U.S. Provisional Patent Application 61/132,295 to Gross et al., entitled, “Annuloplasty devices and methods of delivery therefor,” filed on Jun. 16, 2008;
- U.S. patent application Ser. No. 12/341,960 to Cabin, entitled, “Adjustable partial annuloplasty ring and mechanism therefor,” filed on Dec. 22, 2008, which published as US Patent Application Publication 2010/0161047;
- U.S. Provisional Patent Application 61/207,908 to Miller et al., entitled, “Actively-engageable movement-restriction mechanism for use with an annuloplasty structure,” filed on Feb. 17, 2009;
- U.S. patent application Ser. No. 12/435,291 to Maisano et al., entitled, “Adjustable repair chords and spool mechanism therefor,” filed on May 4, 2009, which published as US Patent Application Publication 2010/0161041;
- U.S. patent application Ser. No. 12/437,103 to Zipory et al., entitled, “Annuloplasty ring with intra-ring anchoring,” filed on May 7, 2009, which published as US Patent Application Publication 2010/0286767;
- PCT Patent Application PCT/IL2009/000593 to Gross et al., entitled, “Annuloplasty devices and methods of delivery therefor,” filed on Jun. 15, 2009, which published as PCT Publication WO 10/004546;
- U.S. patent application Ser. No. 12/548,991 to Maisano et al., entitled, “Implantation of repair chords in the heart,” filed on Aug. 27, 2009, which published as US Patent Application Publication 2010/0161042;
- U.S. patent application Ser. No. 12/608,316 to Miller et al., entitled, “Tissue anchor for annuloplasty ring,” filed on Oct. 29, 2009, which published as US Patent Application Publication 2011/0106247;
- U.S. Provisional Patent Application 61/265,936 to Miller et al., entitled, “Delivery tool for implantation of spool assembly coupled to a helical anchor,” filed Dec. 2, 2009;
- PCT Patent Application PCT/IL2009/001209 to Cabin et al., entitled, “Adjustable annuloplasty devices and mechanisms therefor,” filed on Dec. 22, 2009, which published as PCT Publication WO 10/073246;
- U.S. patent application Ser. No. 12/689,635 to Zipory et al., entitled, “Over-wire rotation tool,” filed on Jan. 19, 2010, which published as US Patent Application Publication 2010/0280604;
- U.S. patent Ser. No. 12/689,693 to Hammer et al., entitled, “Deployment techniques for annuloplasty ring,” filed on Jan. 19, 2010, which published as US Patent Application Publication 2010/0280605;
- U.S. patent application Ser. No. 12/706,868 to Miller et al., entitled, “Actively-engageable movement-restriction mechanism for use with an annuloplasty structure,” filed on Feb. 17, 2010, which published as US Patent Application Publication 2010/0211166;
- PCT Patent Application PCT/IL2010/000357 to Maisano et al., entitled, “Implantation of repair chords in the heart,” filed May 4, 2010, which published as PCT Publication WO 10/128502;
- PCT Patent Application PCT/IL2010/000358 to Zipory et al., entitled, “Deployment techniques for annuloplasty ring and over-wire rotation tool,” filed May 4, 2010, which published as PCT Publication WO 10/128503; and/or
- U.S. patent application Ser. No. 13/167,476 to Hammer et al., filed Jun. 23, 2011, entitled, “Closure element for use with an annuloplasty structure,” which published as US Patent Application Publication 2012/0330410.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.